Elizabeth Mechcatie

Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6-17, the manufacturer announced Feb. 28 in a statement.

The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. Approval of the monotherapy was based on two 8- to 9-week studies, and the adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment. Those who had no response to stimulant therapy were not included in the study.

Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response. At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psychostimulant alone. The prescribing information states that "controlled adjunctive long-term efficacy studies over 9 weeks have not been conducted," and that it is indicated "as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome."

The most common adverse events, reported in 5% or more of patients at a rate of at least twice the placebo rate, were somnolence, fatigue, insomnia, dizziness, and abdominal pain. Most adverse events were mild to moderate, and the four serious adverse events reported in the study – which included syncope and poison ivy – were not considered to be related to the drug, by the investigator, according to the company statement. The discontinuation attributable to side effects was 3% among those on the combination, compared with 1% among those on the stimulant alone, according to the company statement.

Guanfacine is a known antihypertensive, and the labeling cautions about its use with antihypertensive drugs. (It is marketed as an antihypertensive as Tenex, by another manufacturer).

Guanfacine comes in 1-mg, 2-mg, 3-mg and 4-mg extended-release tablets. It should be taken once daily, and should not be taken with high-fat meals, which increases exposure to the drug, according to the prescribing information.

Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6-17, the manufacturer announced Feb. 28 in a statement.

The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. Approval of the monotherapy was based on two 8- to 9-week studies, and the adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment. Those who had no response to stimulant therapy were not included in the study.

Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response. At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psychostimulant alone. The prescribing information states that "controlled adjunctive long-term efficacy studies over 9 weeks have not been conducted," and that it is indicated "as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome."

The most common adverse events, reported in 5% or more of patients at a rate of at least twice the placebo rate, were somnolence, fatigue, insomnia, dizziness, and abdominal pain. Most adverse events were mild to moderate, and the four serious adverse events reported in the study – which included syncope and poison ivy – were not considered to be related to the drug, by the investigator, according to the company statement. The discontinuation attributable to side effects was 3% among those on the combination, compared with 1% among those on the stimulant alone, according to the company statement.

Guanfacine is a known antihypertensive, and the labeling cautions about its use with antihypertensive drugs. (It is marketed as an antihypertensive as Tenex, by another manufacturer).

Guanfacine comes in 1-mg, 2-mg, 3-mg and 4-mg extended-release tablets. It should be taken once daily, and should not be taken with high-fat meals, which increases exposure to the drug, according to the prescribing information.

Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6-17, the manufacturer announced Feb. 28 in a statement.

The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. Approval of the monotherapy was based on two 8- to 9-week studies, and the adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment. Those who had no response to stimulant therapy were not included in the study.

Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response. At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psychostimulant alone. The prescribing information states that "controlled adjunctive long-term efficacy studies over 9 weeks have not been conducted," and that it is indicated "as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome."

The most common adverse events, reported in 5% or more of patients at a rate of at least twice the placebo rate, were somnolence, fatigue, insomnia, dizziness, and abdominal pain. Most adverse events were mild to moderate, and the four serious adverse events reported in the study – which included syncope and poison ivy – were not considered to be related to the drug, by the investigator, according to the company statement. The discontinuation attributable to side effects was 3% among those on the combination, compared with 1% among those on the stimulant alone, according to the company statement.

Guanfacine is a known antihypertensive, and the labeling cautions about its use with antihypertensive drugs. (It is marketed as an antihypertensive as Tenex, by another manufacturer).

Guanfacine comes in 1-mg, 2-mg, 3-mg and 4-mg extended-release tablets. It should be taken once daily, and should not be taken with high-fat meals, which increases exposure to the drug, according to the prescribing information.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season.

The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season.

The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season.

The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

BETHESDA, MD. – The influenza vaccine for the 2011-2012 influenza season in the United States should include the same three strains that are in the current vaccine, a Food and Drug Administration Advisory Panel recommended on Feb. 25.

At a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the panel voted to recommend that the strains in the Northern Hemisphere 2010-11 seasonal influenza vaccine – an A/California/7/2009 (H1N1)–like virus, an A/Perth/16/2009 (H3N2)–like virus, and a B/Brisbane/60/2008–like virus – compose the upcoming vaccine.

This is a preliminary recommendation that will be approved by the FDA in time for vaccine manufacturers to be able to produce an adequate supply for next season. The vaccines panel meets at this time annually to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season. It considers presentations on the latest influenza surveillance, and epidemiology data, antigenic characteristics of recent virus isolates; serologic responses to current vaccines, and availability of candidate vaccine strains and reagents.

Influenza A (H3N2), A (H1N1) and B strains continue to circulate in the United States and globally, and recently characterized strains appear to be well-matched to the components in the current seasonal vaccine, Dr. Lisa Grohskopf, a medical officer in the influenza division at the Centers for Disease Control and Prevention, Atlanta, said at the meeting. The H1N1 virus is a pandemic 2009 H1N1 virus and is the same vaccine virus as was used in the 2009 H1N1 monovalent vaccine.

Recently circulating viruses remain susceptible to neuraminidases, and in recent weeks, influenza activity has remained high, she said. An increase in the proportion of influenza A viruses identified as A (H1N1) have been identified since the beginning of the U.S. season. Of the viruses that have been tested at the CDC since Oct. 1, 13% have been influenza A (H1N1), 54% have been A (H3N2), and 33% have been influenza B.

The panel voted 15-0, with one abstention, in support of the H1N1 strain; the votes in favor of retaining the other two strains were unanimous. However, panelists expressed some concern about the B component, a B/Victoria lineage strain, because of the possibility that a B/Yamagata lineage strain could become an issue. As in past meetings, panelists observed that having a quadrivalent influenza vaccine, with both a B/Victoria and B/Yamagata component, would address these concerns. Although influenza vaccine manufacturers are conducting clinical studies of quadrivalent influenza vaccine, none would be ready for the next season, according to speakers at the meeting. One option discussed was to produce a monovalent vaccine to be used if needed to vaccinate susceptible groups, including children.

An industry representative who spoke at the meeting, Samson Lee, Ph.D., of Sanofi-Pasteur, said that there has been a significant increase in influenza immunization rates among different age groups during the current season, compared with last year: increases of about 18% in the pediatric population, 24% in adults, and 14% in the population aged 65 and older.

To date, 35 pediatric influenza-associated deaths have been reported in the United States this season, including 13 reportedly due to influenza B, 9 due to A (H3N2), and 7 due to A (H1N1). Subtypying was not performed for the remaining 6 cases, Dr. Grohskopf said.

The FDA will consider the recommendations of its advisory panels. Panel members reported having no relevant financial disclosures.

The Food and Drug Administration has granted Genentech a 2-day hearing on the agency’s plan to strip bevacizumab of accelerated approval for the treatment of metastatic breast cancer, the company announced on Feb. 24.

Genentech, a member of the Roche group, has appealed the proposed withdrawal of the indication for bevacizumab (Avastin) in combination with paclitaxel (Taxol) as a first-line treatment of HER2-negative metastatic breast cancer. The decision was based on the failure of a follow-up study to confirm a progression-free survival benefit for the regimen. It followed a near-unanimous recommendation favoring withdrawal by the FDA’s Oncologic Drugs Advisory Committee, which expressed concern about risks associated with treatment.

In 2008, bevacizumab received the accelerated approval for the metastatic breast cancer indication; conversion to full approval was contingent on the confirmation of benefit in follow-up studies. It is approved for other indications, so the drug itself is not being taken off the market.

The hearing is scheduled for June 28-29, 2011. "We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Dr. Hal Barron, chief medical office and head of Global Product Development at Genentech said in the company statement.

The Food and Drug Administration has granted Genentech a 2-day hearing on the agency’s plan to strip bevacizumab of accelerated approval for the treatment of metastatic breast cancer, the company announced on Feb. 24.

Genentech, a member of the Roche group, has appealed the proposed withdrawal of the indication for bevacizumab (Avastin) in combination with paclitaxel (Taxol) as a first-line treatment of HER2-negative metastatic breast cancer. The decision was based on the failure of a follow-up study to confirm a progression-free survival benefit for the regimen. It followed a near-unanimous recommendation favoring withdrawal by the FDA’s Oncologic Drugs Advisory Committee, which expressed concern about risks associated with treatment.

In 2008, bevacizumab received the accelerated approval for the metastatic breast cancer indication; conversion to full approval was contingent on the confirmation of benefit in follow-up studies. It is approved for other indications, so the drug itself is not being taken off the market.

The hearing is scheduled for June 28-29, 2011. "We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Dr. Hal Barron, chief medical office and head of Global Product Development at Genentech said in the company statement.

The Food and Drug Administration has granted Genentech a 2-day hearing on the agency’s plan to strip bevacizumab of accelerated approval for the treatment of metastatic breast cancer, the company announced on Feb. 24.

Genentech, a member of the Roche group, has appealed the proposed withdrawal of the indication for bevacizumab (Avastin) in combination with paclitaxel (Taxol) as a first-line treatment of HER2-negative metastatic breast cancer. The decision was based on the failure of a follow-up study to confirm a progression-free survival benefit for the regimen. It followed a near-unanimous recommendation favoring withdrawal by the FDA’s Oncologic Drugs Advisory Committee, which expressed concern about risks associated with treatment.

In 2008, bevacizumab received the accelerated approval for the metastatic breast cancer indication; conversion to full approval was contingent on the confirmation of benefit in follow-up studies. It is approved for other indications, so the drug itself is not being taken off the market.

The hearing is scheduled for June 28-29, 2011. "We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Dr. Hal Barron, chief medical office and head of Global Product Development at Genentech said in the company statement.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, the Ridascreen Norovirus 3rd Generation EIA assay, "is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.

Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.

These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.

These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.

Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.

The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.

The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.

The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.

Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.