FDA may slap warning on epilepsy meds

Are new warnings on their way for epilepsy meds? The FDA and drugmakers are hashing over the issue: The agency sees a slight increase in risk of suicidal behavior among patients on these drugs; the companies say their own analysis of the data shows no such thing. These days, though, FDA tends to err on the side of caution. And some people who participated in closed-door meetings--of FDA staff, companies, and epilepsy researchers--told the Wall Street Journal that they left feeling certain new warnings are in the cards. An advisory committee will meet next month to discuss.

Lately, the FDA seems particularly focused on psychiatric side effects. Consider Pfizer's Chantix, the stop-smoking drug, which recently got new warnings. Or Acomplia, an obesity drug from Sanofi-Aventis that FDA refused to approve on the basis of psychiatric side effects. Or Singulair, the Merck allergy and asthma med the FDA is now investigating for a possible link to suicidality, based on a handful of patient reports. And in January, the agency instituted new rules for clinical trials, requiring that data be collected specifically on suicide risk for some drugs.

The epilepsy drug case, In Vivo notes, likely will result in extra suicide-related scrutiny for similar meds. Some are saying that the suicide risk varies from drug to drug among the 11 under scrutiny; a Pfizer VP pointed in particular to Lyrica, its epilepsy and pain-management drug, saying that the company gave FDA data on 35 percent of the patients whose data were included in the analysis--but only 6.3 percent of the adverse reports in question came from those patients. The only way to resolve such questions, some researchers say, is for the FDA to release all the data for others to peruse, too.

- read the WSJ Health Blog item
- check out the WSJ article
- find a follow-up in the Health Blog
- get In Vivo's take
- see the clinical trial story in FierceBiotech