Wednesday, July 09, 2008

Another Psych Drug May Get the Black Box


"Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, ...  and psychiatric diseases such as bipolar disorder."


FDA Seeks Suicide Warning
For Anti-Seizure Medications

Associated Press
July 7, 2008 3:49 p.m.

WASHINGTON -- The Food and Drug Administration hopes to add its most serious warning label to epilepsy drugs, based on evidence they increase the risk of suicide in patients.

In materials posted online Monday, 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 Thursday, where outside experts will weigh-in on the drugs' risks.

FDA said in January 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 over $10 billion, according to pharmaceutical research firm IMS Health. Some of the top-sellers included Pfizer's Lyrica and GlaxoSmithKline's Lamictal.