FDA Wants Suicide Warning for Epilepsy Drugs
The U.S. Food and Drug Administration wants to add a "black box" warning detailing an increased risk of suicide connected with drugs used to treat seizures in people with epilepsy.
On its Web site Monday, the FDA said an analysis released in January of nearly 200 studies showed patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking a placebo. While the reports of problems were extremely rare, the agency said drug-treated patients faced about twice the risk of suicide or suicidal thoughts. On average, those patients experienced suicidal thoughts or behavior 0.43 percent of the time, compared with 0.22 percent for those taking a placebo, the Associated Press reported.
The FDA said it was intent on revising the warning labels for all drugs in the class, although it's not entirely clear why they increase suicidal behaviors, the AP said.
"There seems to be no compelling reason to ignore what appears to be a very clear empirical finding of increase in suicidality, despite no obvious explanation," said FDA Director of Neurology Products Russell Katz.
FDA advisers are to consider the black-box proposal at a meeting on June 10, the news service said.