Robert Finn

SAN FRANCISCO — Children aged 10–19 years in Boston were unlikely to be screened for cardiovascular disease risk factors even if they were overweight, according to a large retrospective chart review.

Of 11,081 children, 33% had no family history recorded in their charts. Of the children with any recorded family history, only 46% had a specific mention of the absence or presence of at least one cardiovascular risk factor in any family member, Dr. Shika G. Anand and Dr. William G. Adams of Boston University reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Although more than 95% of the children were screened for hypertension, much smaller percentages were screened for dyslipidemia or abnormal glucose metabolism, even among those who were overweight.

The investigators defined children with a body mass index (BMI) greater than the 95th percentile as being overweight, and children between the 85th and 95th percentile as being at risk for overweight.

Among the 2,795 overweight children, 95% were screened for hypertension, 44% were screened for dyslipidemia, and 36% were screened for abnormal glucose metabolism.

Among the 1,957 children at risk for overweight, 94% were screened for hypertension, 33% were screened for dyslipidemia, and 20% were screened for abnormal glucose metabolism. Overall, 26% of the 10,617 children screened turned out to be positive for hypertension, diabetes, or dyslipidemia.

Subjects in the study included all children aged 10–19 years with at least one primary care visit to Boston Medical Center and at least one recorded BMI during a 2-year period from 2002 to 2004. Pregnant patients were excluded. Of the full sample, 52% were female, 59% were African American, 15% were Hispanic, 6% were white, 2% were Asian American, 1% were Native American, and 17% had an undetermined or other racial classification.

The investigators concluded that there was significant room for improvement in screening for cardiovascular risk factors in pediatric primary care, and that improved screening could be expected to identify a substantial number of overweight children at especially high cardiovascular risk.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — Children aged 10–19 years in Boston were unlikely to be screened for cardiovascular disease risk factors even if they were overweight, according to a large retrospective chart review.

Of 11,081 children, 33% had no family history recorded in their charts. Of the children with any recorded family history, only 46% had a specific mention of the absence or presence of at least one cardiovascular risk factor in any family member, Dr. Shika G. Anand and Dr. William G. Adams of Boston University reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Although more than 95% of the children were screened for hypertension, much smaller percentages were screened for dyslipidemia or abnormal glucose metabolism, even among those who were overweight.

The investigators defined children with a body mass index (BMI) greater than the 95th percentile as being overweight, and children between the 85th and 95th percentile as being at risk for overweight.

Among the 2,795 overweight children, 95% were screened for hypertension, 44% were screened for dyslipidemia, and 36% were screened for abnormal glucose metabolism.

Among the 1,957 children at risk for overweight, 94% were screened for hypertension, 33% were screened for dyslipidemia, and 20% were screened for abnormal glucose metabolism. Overall, 26% of the 10,617 children screened turned out to be positive for hypertension, diabetes, or dyslipidemia.

Subjects in the study included all children aged 10–19 years with at least one primary care visit to Boston Medical Center and at least one recorded BMI during a 2-year period from 2002 to 2004. Pregnant patients were excluded. Of the full sample, 52% were female, 59% were African American, 15% were Hispanic, 6% were white, 2% were Asian American, 1% were Native American, and 17% had an undetermined or other racial classification.

The investigators concluded that there was significant room for improvement in screening for cardiovascular risk factors in pediatric primary care, and that improved screening could be expected to identify a substantial number of overweight children at especially high cardiovascular risk.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — Children aged 10–19 years in Boston were unlikely to be screened for cardiovascular disease risk factors even if they were overweight, according to a large retrospective chart review.

Of 11,081 children, 33% had no family history recorded in their charts. Of the children with any recorded family history, only 46% had a specific mention of the absence or presence of at least one cardiovascular risk factor in any family member, Dr. Shika G. Anand and Dr. William G. Adams of Boston University reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Although more than 95% of the children were screened for hypertension, much smaller percentages were screened for dyslipidemia or abnormal glucose metabolism, even among those who were overweight.

The investigators defined children with a body mass index (BMI) greater than the 95th percentile as being overweight, and children between the 85th and 95th percentile as being at risk for overweight.

Among the 2,795 overweight children, 95% were screened for hypertension, 44% were screened for dyslipidemia, and 36% were screened for abnormal glucose metabolism.

Among the 1,957 children at risk for overweight, 94% were screened for hypertension, 33% were screened for dyslipidemia, and 20% were screened for abnormal glucose metabolism. Overall, 26% of the 10,617 children screened turned out to be positive for hypertension, diabetes, or dyslipidemia.

Subjects in the study included all children aged 10–19 years with at least one primary care visit to Boston Medical Center and at least one recorded BMI during a 2-year period from 2002 to 2004. Pregnant patients were excluded. Of the full sample, 52% were female, 59% were African American, 15% were Hispanic, 6% were white, 2% were Asian American, 1% were Native American, and 17% had an undetermined or other racial classification.

The investigators concluded that there was significant room for improvement in screening for cardiovascular risk factors in pediatric primary care, and that improved screening could be expected to identify a substantial number of overweight children at especially high cardiovascular risk.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3− to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections constitute one of the most common medical causes of agitation. This has inspired a joke: Question: What's the first-line medication for agitation in an in-patient medical unit? Answer: Septra.

Dehydration is another common cause for agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little bit,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an in-patient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of over-the-counter Motrin after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if he or she is told that he's been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patient's choices simple. Three choices of salad dressing and four choices of entrées at mealtimes may be confusing to the demented patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone has a basic need for attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

SAN FRANCISCO — At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3− to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections constitute one of the most common medical causes of agitation. This has inspired a joke: Question: What's the first-line medication for agitation in an in-patient medical unit? Answer: Septra.

Dehydration is another common cause for agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little bit,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an in-patient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of over-the-counter Motrin after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if he or she is told that he's been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patient's choices simple. Three choices of salad dressing and four choices of entrées at mealtimes may be confusing to the demented patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone has a basic need for attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

SAN FRANCISCO — At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3− to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections constitute one of the most common medical causes of agitation. This has inspired a joke: Question: What's the first-line medication for agitation in an in-patient medical unit? Answer: Septra.

Dehydration is another common cause for agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little bit,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an in-patient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of over-the-counter Motrin after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if he or she is told that he's been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patient's choices simple. Three choices of salad dressing and four choices of entrées at mealtimes may be confusing to the demented patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone has a basic need for attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

SAN FRANCISCO – At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3- to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections are one of the most common medical causes of agitation. This has inspired a joke: What's the first-line medication for agitation in an in-patient medical unit? Septra.

Dehydration is another common cause of agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an inpatient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of ibuprofen after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if told he or she has been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patients' choices simple. Three choices of salad dressing and four choices of entrées at meals may be confusing to the patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone needs attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

SAN FRANCISCO – At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3- to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections are one of the most common medical causes of agitation. This has inspired a joke: What's the first-line medication for agitation in an in-patient medical unit? Septra.

Dehydration is another common cause of agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an inpatient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of ibuprofen after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if told he or she has been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patients' choices simple. Three choices of salad dressing and four choices of entrées at meals may be confusing to the patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone needs attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

SAN FRANCISCO – At least 80% of patients with dementia will experience agitation, Dr. Josepha A. Cheong said at the annual meeting of the American Academy of Clinical Psychiatrists. The temptation, especially at in-patient facilities, is to go immediately to medical management for that agitation.

Before reaching for the prescription pad, however, one should rule out any medical causes for that agitation, and then try nonmedical management, which can be highly effective, said Dr. Cheong of the University of Florida, Gainesville.

In dealing with patients with dementia, Dr. Cheong asks herself how she would deal with this patient if he or she were a 3- to 5-year-old child. “Has there ever been a time when you were raising [toddlers] that you wanted to just pull out that syringe of Haldol?” Dr. Cheong asked. “It would be nice, but that's not what we do. One, it's not socially acceptable. And two, it's not appropriate.

“I really feel much the same way in treating agitation in dementia. A lot of times, there's a tendency to go straight to the meds. And there's nothing wrong with that if what's least restrictive has failed.”

Urinary tract infections are one of the most common medical causes of agitation. This has inspired a joke: What's the first-line medication for agitation in an in-patient medical unit? Septra.

Dehydration is another common cause of agitation. “Even if they don't have a urinary tract infection, it's amazing how people will perk up if you just hydrate them a little,” Dr. Cheong said.

Anticholinergics and over-the-counter medications can also result in agitation. Ditropan, which is used for urinary incontinence, is one of the biggest offenders, in Dr. Cheong's view. “I always tell patients and their families: 'Look, it's better to be in Depends than to be demented because of Ditropan.' This can make the difference between keeping someone at home and having them in a nursing home in restraints or in an inpatient unit,” Dr. Cheong said.

Drug interactions can also cause agitation. The combination of an NSAID and lithium is a frequent culprit. A patient taking lithium might turn to a seemingly innocuous dose of ibuprofen after an especially vigorous golf game, and the next thing you know he's in the emergency room suffering from lithium toxicity.

Once medical causes have been excluded, consider whether the patient has experienced a recent change in environment, which can often result in agitation. Has a beloved pet died recently? Has the care facility's routine changed? Is there a new nurse on the ward?

Consider also whether the patient's agitation comes at a certain time of the day, or with certain activities. Shower time often precipitates agitation. One solution is simply not to insist that patients shower daily. Elderly patients often do fine showering or bathing just twice a week, and this has the extra benefit of preventing their skin from drying out.

Another tip is to enter the reality of the patient. People who work in geriatric units are used to seeing patients waiting every morning by the front door for the bus to take them to work. The patient is likely to become upset if told he or she has been retired for 20 years. Instead, it might be better to say, “Why don't you come sit down and have some breakfast while you're waiting?”

Overstimulation and understimulation should both be avoided. The change-of-shift chaos in many in-patient units can be highly disturbing to patients. This might be a good time to have patients away from the chaos in a quiet day room with soothing music. On the other hand, lack of activities and boredom can lead to restless behavior and attempts to escape. Studies show that simply adding a recreational therapist to a nursing-home setting can decrease the amount of agitation that patients experience.

Keep the patients' choices simple. Three choices of salad dressing and four choices of entrées at meals may be confusing to the patient; it's better to provide a single offering. And, just like toddlers, patients with dementia do best with finger foods.

Everyone needs attention, intimacy, and affection. The lack of that human connection can lead to agitation and impulsive sexual behavior. Soothing rituals such as massage or even hair brushing can go a long way to calming the agitated patient.

Psychiatrists may have difficulty getting paid for nonmedical treatment of agitated patients, because Medicare may regard it as psychotherapy, and psychotherapy is not indicated for patients with dementia. Dr. Cheong's tip is to code the treatment as being for behavioral and psychotic symptoms of dementia.

Half of all children undergoing adenotonsillectomy who were found to have attention-deficit hyperactivity disorder before the surgery no longer met the diagnostic criteria a year later, according to a prospective, controlled study.

The study strengthens previous observations linking sleep-disordered breathing–a major reason for adenotonsillectomy–with attention and behavior problems.

The investigators, who were led by Dr. Ronald D. Chervin of the University of Michigan in Ann Arbor, acknowledged that their study does not prove cause and effect.

In addition, they acknowledged that their study still leaves an important puzzle:

Although they found a strong link between adenotonsillectomy and neurobehavioral improvements (behavior, cognition, and sleepiness), they also found that sleep-disordered breathing at baseline and its subsequent improvement did not predict either baseline neurobehavioral morbidity or its improvement in any area aside from sleepiness (Pediatrics 2006;117:e769-e778).

The study involved 78 children between 5 and 13 years of age who were scheduled for adenotonsillectomy for any indication.

These children were compared with 27 control subjects in the same age range who were recruited from other surgical clinics.

Among the children who received adenotonsillectomy, 71 (91%) were judged to have a nocturnal upper airway obstruction.

Children were excluded from the study group if they required a polysomnogram for clinical purposes, if they had a history of treatment for sleep-disordered breathing, or if they had severe medical or neurologic conditions. Children were excluded from the control group for those reasons and also if they had a history of large tonsils, frequent throat infections, adenoidectomy, or tonsillectomy.

At baseline–generally within 1 month before scheduled surgery–all children underwent full-night polysomnography, and the next day received a battery of neurobehavioral assessments including the multiple sleep latency test of daytime sleepiness and a number of neuropsychological tests, Dr. Chervin and his associates said.

Polysomnography and neurobehavioral assessments were repeated at follow-up, approximately 1 year after surgery.

Before surgery, children scheduled to undergo adenotonsillectomy were significantly worse than the control children on several measures of sleep-disordered breathing, including minimum oxygen saturation, an index of obstructive apnea, a respiratory disturbance index, and the apnea-hypopnea index (AHI).

For example, the average AHI of the adenotonsillectomy children was 7.3 events per hour, compared with an average AHI of 1.2 events per hour for the control children, the investigators reported.

A year later, there were no significant differences between the adenotonsillectomy children and the control children on any polysomnographic measure. The average AHI of the control children remained 1.2 events per hour, while that of the adenotonsillectomy children declined to 1.1 per hour.

A total of 22 (28%) of the adenotonsillectomy children had ADHD at baseline, compared with only 2 (7%) of the control children, a significant difference. Of those 22 children, 11 no longer qualified for the diagnosis a year later, and there was no significant difference between the frequencies of ADHD in the two groups.

However, there was no significant association between measures of sleep-disordered breathing and either baseline or follow-up neurobehavioral morbidity.

The lack of an association could reflect inadequate sample size, Dr. Chervin and his associates said, but they noted that the sample size was more than sufficient to identify statistically significant postoperative changes in several other variables.

Another possibility is that standard measures of sleep-disordered breathing may not adequately assess the mild form of this condition that is common among children referred to adenotonsillectomy.

There is also the possibility that some correlate of sleep-disordered breathing, rather than sleep-disordered breathing itself, is the true cause of the neurobehavioral morbidity, the researchers suggested.

Half of all children undergoing adenotonsillectomy who were found to have attention-deficit hyperactivity disorder before the surgery no longer met the diagnostic criteria a year later, according to a prospective, controlled study.

The study strengthens previous observations linking sleep-disordered breathing–a major reason for adenotonsillectomy–with attention and behavior problems.

The investigators, who were led by Dr. Ronald D. Chervin of the University of Michigan in Ann Arbor, acknowledged that their study does not prove cause and effect.

In addition, they acknowledged that their study still leaves an important puzzle:

Although they found a strong link between adenotonsillectomy and neurobehavioral improvements (behavior, cognition, and sleepiness), they also found that sleep-disordered breathing at baseline and its subsequent improvement did not predict either baseline neurobehavioral morbidity or its improvement in any area aside from sleepiness (Pediatrics 2006;117:e769-e778).

The study involved 78 children between 5 and 13 years of age who were scheduled for adenotonsillectomy for any indication.

These children were compared with 27 control subjects in the same age range who were recruited from other surgical clinics.

Among the children who received adenotonsillectomy, 71 (91%) were judged to have a nocturnal upper airway obstruction.

Children were excluded from the study group if they required a polysomnogram for clinical purposes, if they had a history of treatment for sleep-disordered breathing, or if they had severe medical or neurologic conditions. Children were excluded from the control group for those reasons and also if they had a history of large tonsils, frequent throat infections, adenoidectomy, or tonsillectomy.

At baseline–generally within 1 month before scheduled surgery–all children underwent full-night polysomnography, and the next day received a battery of neurobehavioral assessments including the multiple sleep latency test of daytime sleepiness and a number of neuropsychological tests, Dr. Chervin and his associates said.

Polysomnography and neurobehavioral assessments were repeated at follow-up, approximately 1 year after surgery.

Before surgery, children scheduled to undergo adenotonsillectomy were significantly worse than the control children on several measures of sleep-disordered breathing, including minimum oxygen saturation, an index of obstructive apnea, a respiratory disturbance index, and the apnea-hypopnea index (AHI).

For example, the average AHI of the adenotonsillectomy children was 7.3 events per hour, compared with an average AHI of 1.2 events per hour for the control children, the investigators reported.

A year later, there were no significant differences between the adenotonsillectomy children and the control children on any polysomnographic measure. The average AHI of the control children remained 1.2 events per hour, while that of the adenotonsillectomy children declined to 1.1 per hour.

A total of 22 (28%) of the adenotonsillectomy children had ADHD at baseline, compared with only 2 (7%) of the control children, a significant difference. Of those 22 children, 11 no longer qualified for the diagnosis a year later, and there was no significant difference between the frequencies of ADHD in the two groups.

However, there was no significant association between measures of sleep-disordered breathing and either baseline or follow-up neurobehavioral morbidity.

The lack of an association could reflect inadequate sample size, Dr. Chervin and his associates said, but they noted that the sample size was more than sufficient to identify statistically significant postoperative changes in several other variables.

Another possibility is that standard measures of sleep-disordered breathing may not adequately assess the mild form of this condition that is common among children referred to adenotonsillectomy.

There is also the possibility that some correlate of sleep-disordered breathing, rather than sleep-disordered breathing itself, is the true cause of the neurobehavioral morbidity, the researchers suggested.

Half of all children undergoing adenotonsillectomy who were found to have attention-deficit hyperactivity disorder before the surgery no longer met the diagnostic criteria a year later, according to a prospective, controlled study.

The study strengthens previous observations linking sleep-disordered breathing–a major reason for adenotonsillectomy–with attention and behavior problems.

The investigators, who were led by Dr. Ronald D. Chervin of the University of Michigan in Ann Arbor, acknowledged that their study does not prove cause and effect.

In addition, they acknowledged that their study still leaves an important puzzle:

Although they found a strong link between adenotonsillectomy and neurobehavioral improvements (behavior, cognition, and sleepiness), they also found that sleep-disordered breathing at baseline and its subsequent improvement did not predict either baseline neurobehavioral morbidity or its improvement in any area aside from sleepiness (Pediatrics 2006;117:e769-e778).

The study involved 78 children between 5 and 13 years of age who were scheduled for adenotonsillectomy for any indication.

These children were compared with 27 control subjects in the same age range who were recruited from other surgical clinics.

Among the children who received adenotonsillectomy, 71 (91%) were judged to have a nocturnal upper airway obstruction.

Children were excluded from the study group if they required a polysomnogram for clinical purposes, if they had a history of treatment for sleep-disordered breathing, or if they had severe medical or neurologic conditions. Children were excluded from the control group for those reasons and also if they had a history of large tonsils, frequent throat infections, adenoidectomy, or tonsillectomy.

At baseline–generally within 1 month before scheduled surgery–all children underwent full-night polysomnography, and the next day received a battery of neurobehavioral assessments including the multiple sleep latency test of daytime sleepiness and a number of neuropsychological tests, Dr. Chervin and his associates said.

Polysomnography and neurobehavioral assessments were repeated at follow-up, approximately 1 year after surgery.

Before surgery, children scheduled to undergo adenotonsillectomy were significantly worse than the control children on several measures of sleep-disordered breathing, including minimum oxygen saturation, an index of obstructive apnea, a respiratory disturbance index, and the apnea-hypopnea index (AHI).

For example, the average AHI of the adenotonsillectomy children was 7.3 events per hour, compared with an average AHI of 1.2 events per hour for the control children, the investigators reported.

A year later, there were no significant differences between the adenotonsillectomy children and the control children on any polysomnographic measure. The average AHI of the control children remained 1.2 events per hour, while that of the adenotonsillectomy children declined to 1.1 per hour.

A total of 22 (28%) of the adenotonsillectomy children had ADHD at baseline, compared with only 2 (7%) of the control children, a significant difference. Of those 22 children, 11 no longer qualified for the diagnosis a year later, and there was no significant difference between the frequencies of ADHD in the two groups.

However, there was no significant association between measures of sleep-disordered breathing and either baseline or follow-up neurobehavioral morbidity.

The lack of an association could reflect inadequate sample size, Dr. Chervin and his associates said, but they noted that the sample size was more than sufficient to identify statistically significant postoperative changes in several other variables.

Another possibility is that standard measures of sleep-disordered breathing may not adequately assess the mild form of this condition that is common among children referred to adenotonsillectomy.

There is also the possibility that some correlate of sleep-disordered breathing, rather than sleep-disordered breathing itself, is the true cause of the neurobehavioral morbidity, the researchers suggested.

Asystematic review of data on the risks and benefits of omega-3 fatty acids showed no clear benefit for mortality, cardiovascular disease, stroke, or cancer.

In a metaanalysis that included 48 randomized, controlled trials and 41 cohort studies, Lee Hooper, Ph.D., of the University of East Anglia, Norwich, England, and colleagues determined that the lack of effect was even more pronounced when studies with a high risk of bias were excluded (BMJ March 24, 2006;doi:10.1136/bmj.38755.366331.2F).

This result contradicts previous reviews of omega-3 trials that did show a beneficial effect on mortality, perhaps in part because the metaanalysis by Hooper et al includes the recently published results of a large trial. These results differed from the findings of the other large studies on this topic.

Altogether, the metaanalysis included nearly 37,000 participants in randomized, controlled trials as well as more than 560,000 participants in cohort trials. Some of the trials examined consumption of oily fish, while others studied subjects who took supplements.

In an editorial, Eric Brunner, Ph.D., of the Royal Free and University College London Medical School, emphasized that despite the results of this metaanalysis, there still remains good evidence that omega-3 fatty acids are beneficial for health. Extreme nutritional deficiency of these fats results in neuropathy, for example (BMJ March 24, 2006;doi:10.1136/bmj.38798.680185.47).

Furthermore, adequate intake of omega-3 fats is particularly important for women of childbearing age, since an estimated 25 g of maternal docosahexaenoic acid is needed during pregnancy and lactation to support the development of the child's brain.

But Dr. Brunner pointed to a paradox. Although nutrition experts advise increasing consumption of oily fish containing omega-3 fatty acids, industrial fishing has depleted the world's fish stocks by about 90% since 1950, and therefore the world probably doesn't have a sustainable supply of these fats.

Asystematic review of data on the risks and benefits of omega-3 fatty acids showed no clear benefit for mortality, cardiovascular disease, stroke, or cancer.

In a metaanalysis that included 48 randomized, controlled trials and 41 cohort studies, Lee Hooper, Ph.D., of the University of East Anglia, Norwich, England, and colleagues determined that the lack of effect was even more pronounced when studies with a high risk of bias were excluded (BMJ March 24, 2006;doi:10.1136/bmj.38755.366331.2F).

This result contradicts previous reviews of omega-3 trials that did show a beneficial effect on mortality, perhaps in part because the metaanalysis by Hooper et al includes the recently published results of a large trial. These results differed from the findings of the other large studies on this topic.

Altogether, the metaanalysis included nearly 37,000 participants in randomized, controlled trials as well as more than 560,000 participants in cohort trials. Some of the trials examined consumption of oily fish, while others studied subjects who took supplements.

In an editorial, Eric Brunner, Ph.D., of the Royal Free and University College London Medical School, emphasized that despite the results of this metaanalysis, there still remains good evidence that omega-3 fatty acids are beneficial for health. Extreme nutritional deficiency of these fats results in neuropathy, for example (BMJ March 24, 2006;doi:10.1136/bmj.38798.680185.47).

Furthermore, adequate intake of omega-3 fats is particularly important for women of childbearing age, since an estimated 25 g of maternal docosahexaenoic acid is needed during pregnancy and lactation to support the development of the child's brain.

But Dr. Brunner pointed to a paradox. Although nutrition experts advise increasing consumption of oily fish containing omega-3 fatty acids, industrial fishing has depleted the world's fish stocks by about 90% since 1950, and therefore the world probably doesn't have a sustainable supply of these fats.

Asystematic review of data on the risks and benefits of omega-3 fatty acids showed no clear benefit for mortality, cardiovascular disease, stroke, or cancer.

In a metaanalysis that included 48 randomized, controlled trials and 41 cohort studies, Lee Hooper, Ph.D., of the University of East Anglia, Norwich, England, and colleagues determined that the lack of effect was even more pronounced when studies with a high risk of bias were excluded (BMJ March 24, 2006;doi:10.1136/bmj.38755.366331.2F).

This result contradicts previous reviews of omega-3 trials that did show a beneficial effect on mortality, perhaps in part because the metaanalysis by Hooper et al includes the recently published results of a large trial. These results differed from the findings of the other large studies on this topic.

Altogether, the metaanalysis included nearly 37,000 participants in randomized, controlled trials as well as more than 560,000 participants in cohort trials. Some of the trials examined consumption of oily fish, while others studied subjects who took supplements.

In an editorial, Eric Brunner, Ph.D., of the Royal Free and University College London Medical School, emphasized that despite the results of this metaanalysis, there still remains good evidence that omega-3 fatty acids are beneficial for health. Extreme nutritional deficiency of these fats results in neuropathy, for example (BMJ March 24, 2006;doi:10.1136/bmj.38798.680185.47).

Furthermore, adequate intake of omega-3 fats is particularly important for women of childbearing age, since an estimated 25 g of maternal docosahexaenoic acid is needed during pregnancy and lactation to support the development of the child's brain.

But Dr. Brunner pointed to a paradox. Although nutrition experts advise increasing consumption of oily fish containing omega-3 fatty acids, industrial fishing has depleted the world's fish stocks by about 90% since 1950, and therefore the world probably doesn't have a sustainable supply of these fats.

SAN FRANCISCO — Acute hepatitis C infections among individuals who are HIV positive have been documented in four countries, and treatment of this coinfection remains controversial, Dr. Marion G. Peters said at a meeting on HIV management sponsored by the University of California, San Francisco.

The largest outbreak was documented in the United Kingdom, where 210 people from London and surrounding cities were found to be infected. Cases also have been reported in Germany, France, and the United States.

Dr. Peters of the University of California, San Francisco, and her colleagues documented 11 cases of acute HCV infection in the San Francisco Bay Area among men who have sex with men. Presentations varied greatly, ranging from incidental elevations of aspartate aminotransferase and alanine aminotransferase levels to severe liver dysfunction. Ten of the 11 patients had adequate CD4 counts. Five of them had recently had a sexually transmitted disease.

Five patients were treated with interferon and ribavirin, and four of them achieved sustained virologic responses. Six patients were untreated; three of them developed chronic hepatitis C and three seroconverted spontaneously, losing their hepatitis C RNA.

Among the 210 patients with acute hepatitis C documented in London, 64% were on antiretroviral therapy, and their mean CD4 count was 552 cells/mm3, which Dr. Peters described as “perfectly adequate.”

Subtyping identified five clusters of patients. The patients in each of the clusters apparently acquired the virus from a single individual or small set of individuals. One of the clusters contained 43 patients. Genotype 1a was found in 78% of the cases overall. A total of 30% of the patients had had syphilis within the previous year.

A case-control study involving 60 of the 210 patients documented significant levels of high-risk behavior. Patients with acute hepatitis C were more likely than were controls to be users of intravenous drugs. They reported a larger median number of sexual partners and higher levels of Internet dating, one-night stands, group sex, and use of party drugs.

Studies of monogamous couples in which both partners have hepatitis C show that their viruses are rarely identical and that sexual transmission occurs in only 1 case in 500. This suggests that blood-to-blood transmission, perhaps due to traumatic sexual practices, is likely to account for the transmission of hepatitis C in patients who are HIV positive.

Most authorities recommend treating these coinfected patients with interferon and ribavirin, but controversy remains over when to begin treatment after the pinpointed infection event. “We know that if you wait too long the patient will become chronic and then [his or her] chances of responding are very low. So we are fairly aggressive, and if we have a pinpoint of when they acquired [the infection], I would wait 12 weeks.

SAN FRANCISCO — Acute hepatitis C infections among individuals who are HIV positive have been documented in four countries, and treatment of this coinfection remains controversial, Dr. Marion G. Peters said at a meeting on HIV management sponsored by the University of California, San Francisco.

The largest outbreak was documented in the United Kingdom, where 210 people from London and surrounding cities were found to be infected. Cases also have been reported in Germany, France, and the United States.

Dr. Peters of the University of California, San Francisco, and her colleagues documented 11 cases of acute HCV infection in the San Francisco Bay Area among men who have sex with men. Presentations varied greatly, ranging from incidental elevations of aspartate aminotransferase and alanine aminotransferase levels to severe liver dysfunction. Ten of the 11 patients had adequate CD4 counts. Five of them had recently had a sexually transmitted disease.

Five patients were treated with interferon and ribavirin, and four of them achieved sustained virologic responses. Six patients were untreated; three of them developed chronic hepatitis C and three seroconverted spontaneously, losing their hepatitis C RNA.

Among the 210 patients with acute hepatitis C documented in London, 64% were on antiretroviral therapy, and their mean CD4 count was 552 cells/mm3, which Dr. Peters described as “perfectly adequate.”

Subtyping identified five clusters of patients. The patients in each of the clusters apparently acquired the virus from a single individual or small set of individuals. One of the clusters contained 43 patients. Genotype 1a was found in 78% of the cases overall. A total of 30% of the patients had had syphilis within the previous year.

A case-control study involving 60 of the 210 patients documented significant levels of high-risk behavior. Patients with acute hepatitis C were more likely than were controls to be users of intravenous drugs. They reported a larger median number of sexual partners and higher levels of Internet dating, one-night stands, group sex, and use of party drugs.

Studies of monogamous couples in which both partners have hepatitis C show that their viruses are rarely identical and that sexual transmission occurs in only 1 case in 500. This suggests that blood-to-blood transmission, perhaps due to traumatic sexual practices, is likely to account for the transmission of hepatitis C in patients who are HIV positive.

Most authorities recommend treating these coinfected patients with interferon and ribavirin, but controversy remains over when to begin treatment after the pinpointed infection event. “We know that if you wait too long the patient will become chronic and then [his or her] chances of responding are very low. So we are fairly aggressive, and if we have a pinpoint of when they acquired [the infection], I would wait 12 weeks.

SAN FRANCISCO — Acute hepatitis C infections among individuals who are HIV positive have been documented in four countries, and treatment of this coinfection remains controversial, Dr. Marion G. Peters said at a meeting on HIV management sponsored by the University of California, San Francisco.

The largest outbreak was documented in the United Kingdom, where 210 people from London and surrounding cities were found to be infected. Cases also have been reported in Germany, France, and the United States.

Dr. Peters of the University of California, San Francisco, and her colleagues documented 11 cases of acute HCV infection in the San Francisco Bay Area among men who have sex with men. Presentations varied greatly, ranging from incidental elevations of aspartate aminotransferase and alanine aminotransferase levels to severe liver dysfunction. Ten of the 11 patients had adequate CD4 counts. Five of them had recently had a sexually transmitted disease.

Five patients were treated with interferon and ribavirin, and four of them achieved sustained virologic responses. Six patients were untreated; three of them developed chronic hepatitis C and three seroconverted spontaneously, losing their hepatitis C RNA.

Among the 210 patients with acute hepatitis C documented in London, 64% were on antiretroviral therapy, and their mean CD4 count was 552 cells/mm3, which Dr. Peters described as “perfectly adequate.”

Subtyping identified five clusters of patients. The patients in each of the clusters apparently acquired the virus from a single individual or small set of individuals. One of the clusters contained 43 patients. Genotype 1a was found in 78% of the cases overall. A total of 30% of the patients had had syphilis within the previous year.

A case-control study involving 60 of the 210 patients documented significant levels of high-risk behavior. Patients with acute hepatitis C were more likely than were controls to be users of intravenous drugs. They reported a larger median number of sexual partners and higher levels of Internet dating, one-night stands, group sex, and use of party drugs.

Studies of monogamous couples in which both partners have hepatitis C show that their viruses are rarely identical and that sexual transmission occurs in only 1 case in 500. This suggests that blood-to-blood transmission, perhaps due to traumatic sexual practices, is likely to account for the transmission of hepatitis C in patients who are HIV positive.

Most authorities recommend treating these coinfected patients with interferon and ribavirin, but controversy remains over when to begin treatment after the pinpointed infection event. “We know that if you wait too long the patient will become chronic and then [his or her] chances of responding are very low. So we are fairly aggressive, and if we have a pinpoint of when they acquired [the infection], I would wait 12 weeks.

SAN FRANCISCO — The results of an open-label, controlled study suggest that the tuberculin skin test may be an effective wart treatment, Dr. Abdulmajeed Alajlan reported at the annual meeting of the American Academy of Dermatology.

Intrigued by previously reported successes with Candida antigen against warts, Dr. Alajlan of King Saud University in Riyadh, Saudi Arabia, decided to test whether the tuberculin skin test had a similar effect.

The study involved 40 patients with warts who each received a single intradermal injection of the tuberculin skin test directly into one wart, and another 20 patients who received single intradermal injections of normal saline into one wart.

The treatment was repeated in 4 weeks if the patient had no response to the first injection, and this continued for a maximum of three treatments.

In all, 76% of the patients receiving tuberculin skin test responded to the treatment, compared with just 10% of the patients receiving placebo, a statistically significant difference.

Dr. Alajlan noted it was surprising that 36% of the responders experienced clearing of warts not only at the site of the injection, but at distant sites as well. A total of 45% of the responders required only a single treatment.

The only adverse events that Dr. Alajlan noted involved minor pain and swelling at the injection site. He is now conducting a similar study to see if the therapy works in immunocompromised patients as well.

SAN FRANCISCO — The results of an open-label, controlled study suggest that the tuberculin skin test may be an effective wart treatment, Dr. Abdulmajeed Alajlan reported at the annual meeting of the American Academy of Dermatology.

Intrigued by previously reported successes with Candida antigen against warts, Dr. Alajlan of King Saud University in Riyadh, Saudi Arabia, decided to test whether the tuberculin skin test had a similar effect.

The study involved 40 patients with warts who each received a single intradermal injection of the tuberculin skin test directly into one wart, and another 20 patients who received single intradermal injections of normal saline into one wart.

The treatment was repeated in 4 weeks if the patient had no response to the first injection, and this continued for a maximum of three treatments.

In all, 76% of the patients receiving tuberculin skin test responded to the treatment, compared with just 10% of the patients receiving placebo, a statistically significant difference.

Dr. Alajlan noted it was surprising that 36% of the responders experienced clearing of warts not only at the site of the injection, but at distant sites as well. A total of 45% of the responders required only a single treatment.

The only adverse events that Dr. Alajlan noted involved minor pain and swelling at the injection site. He is now conducting a similar study to see if the therapy works in immunocompromised patients as well.

SAN FRANCISCO — The results of an open-label, controlled study suggest that the tuberculin skin test may be an effective wart treatment, Dr. Abdulmajeed Alajlan reported at the annual meeting of the American Academy of Dermatology.

Intrigued by previously reported successes with Candida antigen against warts, Dr. Alajlan of King Saud University in Riyadh, Saudi Arabia, decided to test whether the tuberculin skin test had a similar effect.

The study involved 40 patients with warts who each received a single intradermal injection of the tuberculin skin test directly into one wart, and another 20 patients who received single intradermal injections of normal saline into one wart.

The treatment was repeated in 4 weeks if the patient had no response to the first injection, and this continued for a maximum of three treatments.

In all, 76% of the patients receiving tuberculin skin test responded to the treatment, compared with just 10% of the patients receiving placebo, a statistically significant difference.

Dr. Alajlan noted it was surprising that 36% of the responders experienced clearing of warts not only at the site of the injection, but at distant sites as well. A total of 45% of the responders required only a single treatment.

The only adverse events that Dr. Alajlan noted involved minor pain and swelling at the injection site. He is now conducting a similar study to see if the therapy works in immunocompromised patients as well.

The osteoporosis drug raloxifene is as effective as tamoxifen in preventing invasive breast cancer in postmenopausal women, according to initial results of the Study of Tamoxifen and Raloxifene (STAR) trial. The large, randomized, double-blind trial also determined that women taking raloxifene experienced fewer side effects than did those taking tamoxifen.

Raloxifene is approved for treating and preventing osteoporosis in postmenopausal women. At present, tamoxifen is the only drug approved for reducing breast cancer risk in pre- and postmenopausal women.

“This is good news for women,” said Dr. Leslie Ford, associate director for clinical research in the National Cancer Institute's Division of Cancer Prevention. “We think that this gives women a real choice for addressing two of the leading causes of morbidity and mortality as they age: breast cancer and fractures. … We can't advocate for the off-label use of drugs, but we anticipate that the company that makes raloxifene will be requesting an approval from the [Food and Drug Administration] for breast-cancer risk reduction.”

In the STAR trial, 167 of the 9,745 women in the raloxifene group and 163 of the 9,726 women in the tamoxifen group developed invasive breast cancers. There were no significant differences between the two groups in the risk of developing invasive breast cancer, which was the primary outcome of the trial.

For every 1,000 women similar to the high-risk women enrolled in the STAR trial, about 40 would be expected to develop breast cancer within 5 years if they did not take either drug. The risk would be decreased to about 20 cases of breast cancer for every 1,000 women within 5 years if they took either tamoxifen or raloxifene.

Women taking raloxifene had 36% fewer uterine cancers and 29% fewer blood clots than the women who took tamoxifen.

Dr. D. Lawrence Wickerham, associate chair of the National Surgical Adjuvant Breast and Bowel Project, characterized the results in unusually blunt terms. “We think raloxifene is the winner of this trial,” he said at a joint press briefing held by the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project. The results have not yet been published. Additional data will be presented at the 42nd annual meeting of the American Society for Clinical Oncology (ASCO) to be held in Atlanta, Ga., in June.

The 19,471 women for whom complete information was available took tamoxifen or raloxifene daily for an average of 47 months. The average age of the women in the study was 58. There were no statistically significant differences in the number of fractures of the hip, wrist, and spine, with 100 for in the tamoxifen group and 96 in the raloxifene group.

Raloxifene proved inferior to tamoxifen in only one important measure. Tamoxifen has previously been shown to reduce by about half the incidence of lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS). Of the women taking tamoxifen, 57 developed LCIS or DCIS, compared with 81 of the women taking raloxifene.

The STAR study has been supported to date by $88 million from the National Cancer Institute and $30 million from Eli Lilly & Co., the maker of raloxifene. Both Eli Lilly and AstraZeneca Pharmaceuticals, the maker of tamoxifen, provided their drugs and matching placebos free of charge.

The osteoporosis drug raloxifene is as effective as tamoxifen in preventing invasive breast cancer in postmenopausal women, according to initial results of the Study of Tamoxifen and Raloxifene (STAR) trial. The large, randomized, double-blind trial also determined that women taking raloxifene experienced fewer side effects than did those taking tamoxifen.

Raloxifene is approved for treating and preventing osteoporosis in postmenopausal women. At present, tamoxifen is the only drug approved for reducing breast cancer risk in pre- and postmenopausal women.

“This is good news for women,” said Dr. Leslie Ford, associate director for clinical research in the National Cancer Institute's Division of Cancer Prevention. “We think that this gives women a real choice for addressing two of the leading causes of morbidity and mortality as they age: breast cancer and fractures. … We can't advocate for the off-label use of drugs, but we anticipate that the company that makes raloxifene will be requesting an approval from the [Food and Drug Administration] for breast-cancer risk reduction.”

In the STAR trial, 167 of the 9,745 women in the raloxifene group and 163 of the 9,726 women in the tamoxifen group developed invasive breast cancers. There were no significant differences between the two groups in the risk of developing invasive breast cancer, which was the primary outcome of the trial.

For every 1,000 women similar to the high-risk women enrolled in the STAR trial, about 40 would be expected to develop breast cancer within 5 years if they did not take either drug. The risk would be decreased to about 20 cases of breast cancer for every 1,000 women within 5 years if they took either tamoxifen or raloxifene.

Women taking raloxifene had 36% fewer uterine cancers and 29% fewer blood clots than the women who took tamoxifen.

Dr. D. Lawrence Wickerham, associate chair of the National Surgical Adjuvant Breast and Bowel Project, characterized the results in unusually blunt terms. “We think raloxifene is the winner of this trial,” he said at a joint press briefing held by the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project. The results have not yet been published. Additional data will be presented at the 42nd annual meeting of the American Society for Clinical Oncology (ASCO) to be held in Atlanta, Ga., in June.

The 19,471 women for whom complete information was available took tamoxifen or raloxifene daily for an average of 47 months. The average age of the women in the study was 58. There were no statistically significant differences in the number of fractures of the hip, wrist, and spine, with 100 for in the tamoxifen group and 96 in the raloxifene group.

Raloxifene proved inferior to tamoxifen in only one important measure. Tamoxifen has previously been shown to reduce by about half the incidence of lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS). Of the women taking tamoxifen, 57 developed LCIS or DCIS, compared with 81 of the women taking raloxifene.

The STAR study has been supported to date by $88 million from the National Cancer Institute and $30 million from Eli Lilly & Co., the maker of raloxifene. Both Eli Lilly and AstraZeneca Pharmaceuticals, the maker of tamoxifen, provided their drugs and matching placebos free of charge.

The osteoporosis drug raloxifene is as effective as tamoxifen in preventing invasive breast cancer in postmenopausal women, according to initial results of the Study of Tamoxifen and Raloxifene (STAR) trial. The large, randomized, double-blind trial also determined that women taking raloxifene experienced fewer side effects than did those taking tamoxifen.

Raloxifene is approved for treating and preventing osteoporosis in postmenopausal women. At present, tamoxifen is the only drug approved for reducing breast cancer risk in pre- and postmenopausal women.

“This is good news for women,” said Dr. Leslie Ford, associate director for clinical research in the National Cancer Institute's Division of Cancer Prevention. “We think that this gives women a real choice for addressing two of the leading causes of morbidity and mortality as they age: breast cancer and fractures. … We can't advocate for the off-label use of drugs, but we anticipate that the company that makes raloxifene will be requesting an approval from the [Food and Drug Administration] for breast-cancer risk reduction.”

In the STAR trial, 167 of the 9,745 women in the raloxifene group and 163 of the 9,726 women in the tamoxifen group developed invasive breast cancers. There were no significant differences between the two groups in the risk of developing invasive breast cancer, which was the primary outcome of the trial.

For every 1,000 women similar to the high-risk women enrolled in the STAR trial, about 40 would be expected to develop breast cancer within 5 years if they did not take either drug. The risk would be decreased to about 20 cases of breast cancer for every 1,000 women within 5 years if they took either tamoxifen or raloxifene.

Women taking raloxifene had 36% fewer uterine cancers and 29% fewer blood clots than the women who took tamoxifen.

Dr. D. Lawrence Wickerham, associate chair of the National Surgical Adjuvant Breast and Bowel Project, characterized the results in unusually blunt terms. “We think raloxifene is the winner of this trial,” he said at a joint press briefing held by the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project. The results have not yet been published. Additional data will be presented at the 42nd annual meeting of the American Society for Clinical Oncology (ASCO) to be held in Atlanta, Ga., in June.

The 19,471 women for whom complete information was available took tamoxifen or raloxifene daily for an average of 47 months. The average age of the women in the study was 58. There were no statistically significant differences in the number of fractures of the hip, wrist, and spine, with 100 for in the tamoxifen group and 96 in the raloxifene group.

Raloxifene proved inferior to tamoxifen in only one important measure. Tamoxifen has previously been shown to reduce by about half the incidence of lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS). Of the women taking tamoxifen, 57 developed LCIS or DCIS, compared with 81 of the women taking raloxifene.

The STAR study has been supported to date by $88 million from the National Cancer Institute and $30 million from Eli Lilly & Co., the maker of raloxifene. Both Eli Lilly and AstraZeneca Pharmaceuticals, the maker of tamoxifen, provided their drugs and matching placebos free of charge.

SAN FRANCISCO — The number of hospital admissions for pediatric status asthmaticus seems to be decreasing, but at the same time both the number and the proportion of patients with status asthmaticus who are admitted to the ICU appear to be increasing, Dr. Mary E. Hartman said at the annual congress of the Society of Critical Care Medicine.

In New Jersey over the 10-year period from 1992 to 2001, ICU admissions for status asthmaticus increased from 10 per 100,000 children to 18 per 100,000, an increase of 80%, said Dr. Hartman of the University of Pittsburgh.

At the same time, total hospital admissions for status asthmaticus declined from 4,170 in 1992 to 2,361 in 2001, a decline of 43%.

Dr. Hartman and her colleagues examined an administrative database from New Jersey that tabulated every pediatric hospitalization in the state's hospitals. For the years 1992, 1995, 1999, 2000, and 2001, the investigators identified all admissions with the ICD-9 codes for status asthmaticus.

The database included demographic information as well as information on admission characteristics such as length of stay and whether the child was admitted to an ICU.

The investigators were also able to determine which of the 108 hospitals had a pediatric ICU (PICU) and which had only an adult ICU or no ICU at all.

During the 10-year period, there were 17,066 pediatric status asthmaticus admissions. Fifty-nine percent of the children were male, and 70% were less than 10 years old. The proportion of uninsured children was 8.1%. These demographic characteristics did not change appreciably over the study period.

Overall, 9.3% of status asthmaticus admissions involved an ICU stay. But that increased from 4.4% in 1992 to 17.7% in 2001.

This pattern of increased ICU use did not reflect overall trends in hospitalization during that period. When all hospitalizations and all ICU admissions were considered, total pediatric hospitalizations decreased just 9%, compared with 43% for status asthmaticus. Likewise, total pediatric ICU cases increased by 51%, compared with 127% for status asthmaticus.

Deaths were infrequent during the study period and remained stable over time. A total of eight children died during the 5 years studied. On the other hand, the number of children who required mechanical ventilation declined steadily from 1995 to 2001.

“The drop in ventilated cases corresponds to an increase in ICU admissions during that time, and we believe that these data represent a trend in increased vigilance … toward more aggressive management of status asthmaticus patients in the ICU,” Dr. Hartman said.

One of the more interesting aspects of the study concerned whether children were admitted to a PICU or to an adult ICU. Despite the fact that only 17 of 108 hospitals had a PICU, three-quarters of the children with status asthmaticus who needed intensive care were seen in PICUs. In 1992, only 8% of all admissions for status asthmaticus received intensive care in PICU hospitals. By 2001, 40% of all such admissions ended up in the PICU.

“Adult hospitals are not performing the same way [as children's hospitals],” Dr. Hartman said. “While the overall trends are the same—[adult hospitals] did indeed lower the total number of admissions and also had a higher proportion of admitted patients cared for in the ICU over 10 years—the size of this change is minuscule, compared to what was happening in children's hospitals.”

Dr. Hartman suggested that hospitals with PICUs may have more effective triage than hospitals with only adult ICU beds. “Adult hospitals still have far too many lower-acuity admissions for status asthmaticus,” she said.

“If there's one take-home point I'd like you all to remember today, it's that ICU admissions for status asthmaticus are increasing linearly over time,” she continued.

“We need to ask ourselves if we're prepared for the increase in admissions that is certainly ahead. Second, I think this study clearly raises questions about the regionalization of ICU care. Children's hospitals have changed in ways adult hospitals have not.”

SAN FRANCISCO — The number of hospital admissions for pediatric status asthmaticus seems to be decreasing, but at the same time both the number and the proportion of patients with status asthmaticus who are admitted to the ICU appear to be increasing, Dr. Mary E. Hartman said at the annual congress of the Society of Critical Care Medicine.

In New Jersey over the 10-year period from 1992 to 2001, ICU admissions for status asthmaticus increased from 10 per 100,000 children to 18 per 100,000, an increase of 80%, said Dr. Hartman of the University of Pittsburgh.

At the same time, total hospital admissions for status asthmaticus declined from 4,170 in 1992 to 2,361 in 2001, a decline of 43%.

Dr. Hartman and her colleagues examined an administrative database from New Jersey that tabulated every pediatric hospitalization in the state's hospitals. For the years 1992, 1995, 1999, 2000, and 2001, the investigators identified all admissions with the ICD-9 codes for status asthmaticus.

The database included demographic information as well as information on admission characteristics such as length of stay and whether the child was admitted to an ICU.

The investigators were also able to determine which of the 108 hospitals had a pediatric ICU (PICU) and which had only an adult ICU or no ICU at all.

During the 10-year period, there were 17,066 pediatric status asthmaticus admissions. Fifty-nine percent of the children were male, and 70% were less than 10 years old. The proportion of uninsured children was 8.1%. These demographic characteristics did not change appreciably over the study period.

Overall, 9.3% of status asthmaticus admissions involved an ICU stay. But that increased from 4.4% in 1992 to 17.7% in 2001.

This pattern of increased ICU use did not reflect overall trends in hospitalization during that period. When all hospitalizations and all ICU admissions were considered, total pediatric hospitalizations decreased just 9%, compared with 43% for status asthmaticus. Likewise, total pediatric ICU cases increased by 51%, compared with 127% for status asthmaticus.

Deaths were infrequent during the study period and remained stable over time. A total of eight children died during the 5 years studied. On the other hand, the number of children who required mechanical ventilation declined steadily from 1995 to 2001.

“The drop in ventilated cases corresponds to an increase in ICU admissions during that time, and we believe that these data represent a trend in increased vigilance … toward more aggressive management of status asthmaticus patients in the ICU,” Dr. Hartman said.

One of the more interesting aspects of the study concerned whether children were admitted to a PICU or to an adult ICU. Despite the fact that only 17 of 108 hospitals had a PICU, three-quarters of the children with status asthmaticus who needed intensive care were seen in PICUs. In 1992, only 8% of all admissions for status asthmaticus received intensive care in PICU hospitals. By 2001, 40% of all such admissions ended up in the PICU.

“Adult hospitals are not performing the same way [as children's hospitals],” Dr. Hartman said. “While the overall trends are the same—[adult hospitals] did indeed lower the total number of admissions and also had a higher proportion of admitted patients cared for in the ICU over 10 years—the size of this change is minuscule, compared to what was happening in children's hospitals.”

Dr. Hartman suggested that hospitals with PICUs may have more effective triage than hospitals with only adult ICU beds. “Adult hospitals still have far too many lower-acuity admissions for status asthmaticus,” she said.

“If there's one take-home point I'd like you all to remember today, it's that ICU admissions for status asthmaticus are increasing linearly over time,” she continued.

“We need to ask ourselves if we're prepared for the increase in admissions that is certainly ahead. Second, I think this study clearly raises questions about the regionalization of ICU care. Children's hospitals have changed in ways adult hospitals have not.”

SAN FRANCISCO — The number of hospital admissions for pediatric status asthmaticus seems to be decreasing, but at the same time both the number and the proportion of patients with status asthmaticus who are admitted to the ICU appear to be increasing, Dr. Mary E. Hartman said at the annual congress of the Society of Critical Care Medicine.

In New Jersey over the 10-year period from 1992 to 2001, ICU admissions for status asthmaticus increased from 10 per 100,000 children to 18 per 100,000, an increase of 80%, said Dr. Hartman of the University of Pittsburgh.

At the same time, total hospital admissions for status asthmaticus declined from 4,170 in 1992 to 2,361 in 2001, a decline of 43%.

Dr. Hartman and her colleagues examined an administrative database from New Jersey that tabulated every pediatric hospitalization in the state's hospitals. For the years 1992, 1995, 1999, 2000, and 2001, the investigators identified all admissions with the ICD-9 codes for status asthmaticus.

The database included demographic information as well as information on admission characteristics such as length of stay and whether the child was admitted to an ICU.

The investigators were also able to determine which of the 108 hospitals had a pediatric ICU (PICU) and which had only an adult ICU or no ICU at all.

During the 10-year period, there were 17,066 pediatric status asthmaticus admissions. Fifty-nine percent of the children were male, and 70% were less than 10 years old. The proportion of uninsured children was 8.1%. These demographic characteristics did not change appreciably over the study period.

Overall, 9.3% of status asthmaticus admissions involved an ICU stay. But that increased from 4.4% in 1992 to 17.7% in 2001.

This pattern of increased ICU use did not reflect overall trends in hospitalization during that period. When all hospitalizations and all ICU admissions were considered, total pediatric hospitalizations decreased just 9%, compared with 43% for status asthmaticus. Likewise, total pediatric ICU cases increased by 51%, compared with 127% for status asthmaticus.

Deaths were infrequent during the study period and remained stable over time. A total of eight children died during the 5 years studied. On the other hand, the number of children who required mechanical ventilation declined steadily from 1995 to 2001.

“The drop in ventilated cases corresponds to an increase in ICU admissions during that time, and we believe that these data represent a trend in increased vigilance … toward more aggressive management of status asthmaticus patients in the ICU,” Dr. Hartman said.

One of the more interesting aspects of the study concerned whether children were admitted to a PICU or to an adult ICU. Despite the fact that only 17 of 108 hospitals had a PICU, three-quarters of the children with status asthmaticus who needed intensive care were seen in PICUs. In 1992, only 8% of all admissions for status asthmaticus received intensive care in PICU hospitals. By 2001, 40% of all such admissions ended up in the PICU.

“Adult hospitals are not performing the same way [as children's hospitals],” Dr. Hartman said. “While the overall trends are the same—[adult hospitals] did indeed lower the total number of admissions and also had a higher proportion of admitted patients cared for in the ICU over 10 years—the size of this change is minuscule, compared to what was happening in children's hospitals.”

Dr. Hartman suggested that hospitals with PICUs may have more effective triage than hospitals with only adult ICU beds. “Adult hospitals still have far too many lower-acuity admissions for status asthmaticus,” she said.

“If there's one take-home point I'd like you all to remember today, it's that ICU admissions for status asthmaticus are increasing linearly over time,” she continued.

“We need to ask ourselves if we're prepared for the increase in admissions that is certainly ahead. Second, I think this study clearly raises questions about the regionalization of ICU care. Children's hospitals have changed in ways adult hospitals have not.”

The Food and Drug Administration's approval of a transdermal methyl-phenidate patch for the treatment of attention-deficit hyperactivity disorder in children could broaden use of the drug for patients who need it.

“Some patients may have difficulty swallowing the tablets, and patients may prefer to use the patch,” Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School, Boston, said in an interview. “So it's a technology that may allow physicians to expand the repertoire of choices.”

Dr. Thomas Laughren, director of the FDA's division of psychiatric products in Rockville, Md., agreed. During a meeting of the FDA's Psychopharmacologic Drugs Advisory Panel in December, the agency heard from several advisers and others that a “substantial fraction” of children have difficulty taking pills, Dr. Laughren said during a media teleconference sponsored by the FDA. “They felt that this would be an important addition to the available treatments for ADHD.”

Dr. Richard Gorman said in an interview that he also thinks that another dosage form will open use of the drug for patients who have had difficulty with methylphenidate in the past. “Whether it will be widely accepted or not I think is still an open question,” said Dr. Gorman, chairman of the section of clinical pharmacology and therapeutics for the American Academy of Pediatrics.

It is important to note that use of a patch by young children would require intervention by a responsible adult at specific times twice a day, compared with just once a day for oral forms of methylphenidate, said Dr. Gorman, a pediatrician in private practice in Baltimore. The approval applies to children aged 6–11 years.

Approval of the patch—called Daytrana and codeveloped by Shire Pharmaceuticals Inc. and Noven Pharmaceuticals Inc.—had been widely expected after the panel's endorsement. But the panel, citing the patch's potential to cause sensitization to methylphenidate, questioned how strong the warnings on the label would be.

Sensitization can occur with any medication delivered using a transdermal patch. People sometimes develop antibodies to the medication in transdermal patches, and when they are later challenged with an oral version of the medication, they may experience an allergic reaction. Theoretically, this could prevent a child who had used the methylphenidate patch from ever taking an oral form of the medication.

Dr. Laughren said such a sensitization reaction had never been seen in 765 patients exposed to methylphenidate patches in short-term trials. In one case that had been thought to involve sensitization, further study showed that sensitization did not occur. However, a separate provocation study with treatment for an extended period of time indicated that sensitization could be a possibility.

At the panel meeting, a spokesperson for Shire Pharmaceuticals cited two studies of children aged 6–12 years with ADHD—a 2-day laboratory classroom study of 93 children and a pivotal multicenter outpatient study of 274 children that compared the patch with oral methylphenidate (Concerta) and placebo over 7 weeks. Significant improvements in behavior were seen within 2 hours of application of the patch (left on for 9 hours) and persisted for 3 hours after removal, the company said.

The label instructions call for the patch to be left on for a maximum of 9 hours, but Dr. Biederman said that it can be left on for longer than 9 hours for a longer duration of effect. “We know from the early studies that the patch continues to work for about 2 hours after it's removed,” he said. “So it may permit clinicians and families to actually vary the duration of effect, depending on the individual needs of the particular day, week, or month.”

Normally, the patch is to be applied to alternating areas of the child's thighs each morning and removed later that day. But in the provocation study, patches were applied to a single area and left on continuously for days at a time, and 13% of patients did develop sensitivity.

For that reason, the label of the product as it will be released contains advice for physicians on how to recognize and manage sensitization. Redness at the patch site is very common and does not by itself indicate sensitization. The patch will be available in four dosages: 10 mg, 15 mg, 20 mg, and 30 mg.

The Food and Drug Administration's approval of a transdermal methyl-phenidate patch for the treatment of attention-deficit hyperactivity disorder in children could broaden use of the drug for patients who need it.

“Some patients may have difficulty swallowing the tablets, and patients may prefer to use the patch,” Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School, Boston, said in an interview. “So it's a technology that may allow physicians to expand the repertoire of choices.”

Dr. Thomas Laughren, director of the FDA's division of psychiatric products in Rockville, Md., agreed. During a meeting of the FDA's Psychopharmacologic Drugs Advisory Panel in December, the agency heard from several advisers and others that a “substantial fraction” of children have difficulty taking pills, Dr. Laughren said during a media teleconference sponsored by the FDA. “They felt that this would be an important addition to the available treatments for ADHD.”

Dr. Richard Gorman said in an interview that he also thinks that another dosage form will open use of the drug for patients who have had difficulty with methylphenidate in the past. “Whether it will be widely accepted or not I think is still an open question,” said Dr. Gorman, chairman of the section of clinical pharmacology and therapeutics for the American Academy of Pediatrics.

It is important to note that use of a patch by young children would require intervention by a responsible adult at specific times twice a day, compared with just once a day for oral forms of methylphenidate, said Dr. Gorman, a pediatrician in private practice in Baltimore. The approval applies to children aged 6–11 years.

Approval of the patch—called Daytrana and codeveloped by Shire Pharmaceuticals Inc. and Noven Pharmaceuticals Inc.—had been widely expected after the panel's endorsement. But the panel, citing the patch's potential to cause sensitization to methylphenidate, questioned how strong the warnings on the label would be.

Sensitization can occur with any medication delivered using a transdermal patch. People sometimes develop antibodies to the medication in transdermal patches, and when they are later challenged with an oral version of the medication, they may experience an allergic reaction. Theoretically, this could prevent a child who had used the methylphenidate patch from ever taking an oral form of the medication.

Dr. Laughren said such a sensitization reaction had never been seen in 765 patients exposed to methylphenidate patches in short-term trials. In one case that had been thought to involve sensitization, further study showed that sensitization did not occur. However, a separate provocation study with treatment for an extended period of time indicated that sensitization could be a possibility.

At the panel meeting, a spokesperson for Shire Pharmaceuticals cited two studies of children aged 6–12 years with ADHD—a 2-day laboratory classroom study of 93 children and a pivotal multicenter outpatient study of 274 children that compared the patch with oral methylphenidate (Concerta) and placebo over 7 weeks. Significant improvements in behavior were seen within 2 hours of application of the patch (left on for 9 hours) and persisted for 3 hours after removal, the company said.

The label instructions call for the patch to be left on for a maximum of 9 hours, but Dr. Biederman said that it can be left on for longer than 9 hours for a longer duration of effect. “We know from the early studies that the patch continues to work for about 2 hours after it's removed,” he said. “So it may permit clinicians and families to actually vary the duration of effect, depending on the individual needs of the particular day, week, or month.”

Normally, the patch is to be applied to alternating areas of the child's thighs each morning and removed later that day. But in the provocation study, patches were applied to a single area and left on continuously for days at a time, and 13% of patients did develop sensitivity.

For that reason, the label of the product as it will be released contains advice for physicians on how to recognize and manage sensitization. Redness at the patch site is very common and does not by itself indicate sensitization. The patch will be available in four dosages: 10 mg, 15 mg, 20 mg, and 30 mg.

The Food and Drug Administration's approval of a transdermal methyl-phenidate patch for the treatment of attention-deficit hyperactivity disorder in children could broaden use of the drug for patients who need it.

“Some patients may have difficulty swallowing the tablets, and patients may prefer to use the patch,” Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School, Boston, said in an interview. “So it's a technology that may allow physicians to expand the repertoire of choices.”

Dr. Thomas Laughren, director of the FDA's division of psychiatric products in Rockville, Md., agreed. During a meeting of the FDA's Psychopharmacologic Drugs Advisory Panel in December, the agency heard from several advisers and others that a “substantial fraction” of children have difficulty taking pills, Dr. Laughren said during a media teleconference sponsored by the FDA. “They felt that this would be an important addition to the available treatments for ADHD.”

Dr. Richard Gorman said in an interview that he also thinks that another dosage form will open use of the drug for patients who have had difficulty with methylphenidate in the past. “Whether it will be widely accepted or not I think is still an open question,” said Dr. Gorman, chairman of the section of clinical pharmacology and therapeutics for the American Academy of Pediatrics.

It is important to note that use of a patch by young children would require intervention by a responsible adult at specific times twice a day, compared with just once a day for oral forms of methylphenidate, said Dr. Gorman, a pediatrician in private practice in Baltimore. The approval applies to children aged 6–11 years.

Approval of the patch—called Daytrana and codeveloped by Shire Pharmaceuticals Inc. and Noven Pharmaceuticals Inc.—had been widely expected after the panel's endorsement. But the panel, citing the patch's potential to cause sensitization to methylphenidate, questioned how strong the warnings on the label would be.

Sensitization can occur with any medication delivered using a transdermal patch. People sometimes develop antibodies to the medication in transdermal patches, and when they are later challenged with an oral version of the medication, they may experience an allergic reaction. Theoretically, this could prevent a child who had used the methylphenidate patch from ever taking an oral form of the medication.

Dr. Laughren said such a sensitization reaction had never been seen in 765 patients exposed to methylphenidate patches in short-term trials. In one case that had been thought to involve sensitization, further study showed that sensitization did not occur. However, a separate provocation study with treatment for an extended period of time indicated that sensitization could be a possibility.

At the panel meeting, a spokesperson for Shire Pharmaceuticals cited two studies of children aged 6–12 years with ADHD—a 2-day laboratory classroom study of 93 children and a pivotal multicenter outpatient study of 274 children that compared the patch with oral methylphenidate (Concerta) and placebo over 7 weeks. Significant improvements in behavior were seen within 2 hours of application of the patch (left on for 9 hours) and persisted for 3 hours after removal, the company said.

The label instructions call for the patch to be left on for a maximum of 9 hours, but Dr. Biederman said that it can be left on for longer than 9 hours for a longer duration of effect. “We know from the early studies that the patch continues to work for about 2 hours after it's removed,” he said. “So it may permit clinicians and families to actually vary the duration of effect, depending on the individual needs of the particular day, week, or month.”

Normally, the patch is to be applied to alternating areas of the child's thighs each morning and removed later that day. But in the provocation study, patches were applied to a single area and left on continuously for days at a time, and 13% of patients did develop sensitivity.

For that reason, the label of the product as it will be released contains advice for physicians on how to recognize and manage sensitization. Redness at the patch site is very common and does not by itself indicate sensitization. The patch will be available in four dosages: 10 mg, 15 mg, 20 mg, and 30 mg.