FDA Warns of Suicide Risk for Seizure Medications
The risk of suicidal thoughts and behavior is twofold for patients taking any of 11 seizure drugs, which also are used for pain, mental illness and other disorders, FDA announced in an alert to physicians on Thursday, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 2/1).
The warning, posted on the agency's Web site, states that patients using the drugs "should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression." The drugs include Johnson & Johnson's Topamax; Pfizer's Lyrica and Neurontin; GlaxoSmithKline's Lamictal; and Novartis' Tegretol and Trileptal, among others (Corbett Dooren, Dow Jones, 1/31).
FDA's warning is based on an analysis of nearly 200 studies of seizure drugs involving about 28,000 people who took the treatments and about 16,000 people who took placebos (AP/Chicago Tribune, 1/31). The analysis found that among patients who used the drugs, there were four suicides and 105 reports of suicidal behavior. There were no suicides and 35 reports of suicidal behavior among those who took placebos, the analysis found. The analysis found that risk of suicidal behavior was 0.43% for those taking the drugs, compared to 0.22% for those on placebos.
According to the New York Times, "The increased risks, while double in relative terms, are small." Physicians on Thursday said that the suicide risks do not outweigh the benefits of such drugs (Harris/Carey, New York Times, 2/1.)
Some of the drugs already carry warnings of increased suicide risk on their labels. FDA spokesperson Sandy Walsh on Thursday said that new wording on labels might be more prominent. She said the agency will schedule meetings with advisory committees over the next three months to seek recommendations (Bloomberg/Dallas Morning News, 1/31).