FDA Asks For Suicide Warning On Anti-Seizure Medications
The FDA expects to affix its most serious warning label to epilepsy drugs, based on new evidence that the drugs increase the risk of suicide in patients. In materials posted online on July 7, 2008, FDA scientists proposed adding a “black box” warning about suicide risks to all drugs used to treat seizures.
The agency released the proposal ahead of a meeting on July 10, 2008 where outside experts will weigh-in on the drugs’ risks. The FDA said in January 2008, its analysis of nearly 200 studies showed patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking dummy pills.
While the reported problems were extremely rare, FDA found drug-treated patients did face about twice the risk. On average, those patients experienced suicidal thoughts or behavior 0.43% of the time, compared with 0.22% of those taking dummy pills.
FDA scientists said they are determined to move forward with revised warning labels for all drugs in the class, although it is not entirely understood why they increase suicidal behaviors.
“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,” states FDA Director of Neurology Products Russell Katz, in the briefing documents posted online.
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.
Seizure drugs were the fifth best-selling class of drugs in the U.S. last year, with sales in excess of $10 billion, according to pharmaceutical research firm IMS Health. Some of the top-sellers included Pfizer’s Lyrica and GlaxoSmithKline’s Lamictal.