The announcement comes days ahead of an FDA advisory panel meeting to discuss concerns about the drugs. According to documents posted on the agency's Web site Monday, a committee of outside medical experts will discuss suicidal behavior associated with epilepsy drugs at an FDA-sponsored meeting on Thursday.
FDA scientists proposed adding a "black box" warning about suicide risks to all drugs used to treat seizures. Last month a federal report concluded epilepsy drugs are associated with a higher risk of suicidal tendencies. The drugs that will be affected by the new label warning include Pfizer Inc.'s Lyrica, Cephalon Inc.'s Gabitril and Novartis AG's Trileptal.
According to DowJones, sales of the affected drugs, widely used for non anti-seizure problems such as chronic pain, topped $8 billion last year. In addition to epilepsy, the drugs are used to treat migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.
