Elizabeth Mechcatie

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

The risk of sexually transmitted HIV was reduced by 96% when the infected partner received a combination of three or more antiretroviral drugs, according to the findings of an international study involving 1,763 serodiscordant couples.

The results "are the first from a major randomized trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner," according to a statement issued by the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the study.

Previous studies on the ability of antiretrovirals to prevent sexual transmission of HIV were either observational and epidemiologic.

Results from the current randomized study were so striking that the trial, which began in April 2005 and was slated to continue into 2015, was halted early. The study has not yet been published; the results were reported in the NIAID statement.

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID director Dr. Anthony Fauci said in the statement.

The study enrolled 1,763 mostly heterosexual serodiscordant couples aged 18 years and older in several African countries, Brazil, India, Thailand, and the United States. The HIV-infected partners were randomly assigned to either immediately start triple or quadruple antiretroviral therapy, or to a deferred-treatment group that started therapy only after their CD4 counts dropped below 250 cells/mm³, or they developed pneumocystis pneumonia, or another AIDS-related event. All couples received information and counseling about safe sex and were treated for any HIV-related complications.

There were 39 previously uninfected partners who became infected with HIV; genetic analyses of the viruses in both partners determined that 28 of these individuals were infected from their HIV-infected partners, 7 were infected by another sexual partner, and the results of the remaining 4 have not yet been determined.

Of the 28 cases that were determined to be from the sexual partner in the study, 27 were among the 877 serodiscordant couples in the deferred-treatment group; only one case occurred among those in the immediate-treatment group. This highly significant difference corresponded to a 96% risk reduction attributed to immediate therapy, and spurred the independent data and safety monitoring board’s recommendation that the deferred-treatment arm be stopped early.

In addition to evaluating the impact of antiretroviral therapy on sexual transmission of HIV, the investigators looked at whether immediate treatment altered the course of disease in the HIV-infected individuals. Among the HIV-infected partners in the deferred-treatment group, there were 17 cases of extrapulmonary tuberculosis, compared with 3 cases among the infected partners in the immediate-treatment group, a significant difference. The number of deaths, however, was not significantly different: Ten deaths occurred in the immediate-treatment group versus 13 in the deferred-treatment group.

The study was conducted by the HIV Prevention Trials Network, largely funded by NIAID, and also received funding from the National Institute on Drug Abuse and the National Institute of Mental Health; the AIDS Clinical Trials Group, funded by NIAID, also provided support for the study. The 11 antiretroviral drugs used in various combinations in the in the study were provided by the manufacturers, Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline/ViiV Healthcare; and Merck.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

For patients with a history of myocardial infarction, any length of treatment with nonsteroidal anti-inflammatory drugs poses an unacceptably high risk for death or recurrent heart attack, based on findings from a Danish study using hospital and pharmacy registry data and published online May 9 in Circulation.

The risk elevation began during the first week of therapy and continued throughout the course of treatment, with some differences in the magnitude of risk between NSAIDs.

"These results challenge the view that NSAIDs are not harmful during short-term [1-week] treatment and indicate that a revision of current recommendations regarding NSAID treatment in patients with established cardiovascular disease is required," concluded Anne-Marie Schjerning of the department of cardiology, Copenhagen University Hospital in Gentofte, Denmark, and her coauthors. (Circulation 2011 May 9 [doi: 0.1161/CIRCULATIONAHA.110.004671]).

The significant increase in death and recurrent myocardial infarction associated with the use of NSAIDs in a study of people with a history of myocardial infarction indicates that current recommendations regarding NSAID use in patients with cardiovascular disease need to be revised, the study authors concluded.

Although international guidelines state that NSAID use should be discouraged in people with established cardiovascular disease, they say that if such use is unavoidable, the duration of NSAID treatment "should be as short as possible," the authors pointed out.

The investigators conducted the study to address the paucity of information on the association between the duration of treatment with NSAIDs and the risk of cardiovascular disease, in this population of patients. Of the 83,675 people aged 30 years and older who had had their first MI from 1997 through 2006 identified in the national registries (mean age, 68 years), 42% had received NSAIDs.

Overall, treatment with NSAIDs was associated with a 45% greater risk of death/recurrent MI during the first 7 days of treatment, which persisted and was increased by 65% over a 30- to 90-day period of treatment.

The greatest risk identified was with diclofenac (hazard ratio, 3.26; 95% confidence interval, 2.57-3.86 for death/MI at day 1-7 of treatment). Diclofenac is available over the counter in many countries, the authors noted.

A significant increase in risk was seen after 1 week of treatment with ibuprofen, in the first week of treatment with rofecoxib (which has been withdrawn from the market), and after 14-30 days with celecoxib. The risk associated with ibuprofen was lower than the risk associated with the two cyclo-oxygenase-2 (COX-2) selective inhibitors, rofecoxib and celecoxib, and it was lower than the risk associated with the use of diclofenac. There was no increased risk of death or recurrent MI associated with naproxen for the entire treatment duration, which exceeded 90 days in some cases. However, naproxen has been associated with an increased risk of GI bleeding, compared with rofecoxib, in one study, the authors noted.

The results of the study "challenge" American Heart Association recommendations regarding NSAID treatment in patients with established cardiovascular disease "because we demonstrate that even short-term NSAID treatment is associated with increased cardiovascular risk in patients with prior MI," the authors stressed.

Despite some limitations of the study, namely the observational design and the possible effects of information bias, and the need for randomized clinical studies, the investigators added: "The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease."

The authors said they had no relevant financial disclosures.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA's Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA's Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.

The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.

Photo credit: U.S. Food & Drug Administration

The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.

Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA's Office of Regulatory Affairs.

The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.

The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.

One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.

Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.