It was a close shave for 11 epilepsy drugs yesterday. An FDA advisory panel agreed that they may raise the risk of suicide--but not enough to warrant a "black box" warning on their labels. You'll recall that the agency did a meta-analysis of trial data and found higher rates of suicidal behavior and thinking in dozens of studies. FDA staffers have been indicating for weeks that they intended to issue a warning based on that analysis. And that warning would affect products made by almost every big name in pharma: GlaxoSmithKline, Pfizer, Merck, et al.
It wasn't a close vote at the meeting, however; 14 panelists voted against a "black box", with four in favor and three abstaining. The expert panelists did recommend sending a medication guide to doctors that details the risk of suicide possible with these meds. And in a separate vote the panelists affirmed the agency's conclusions about the suicide risks. Despite voting against the "black box," one panelist said, "I do think there's a serious need to communicate this knowledge." The panelists just wanted to make sure that the warning wasn't so strong that it scared patients off drug therapy.
The 11 meds--which bring in a combined $10 billion-plus annually--aren't totally out of the woods yet. The FDA generally follows its panels' advice, but doesn't have to. You can bet the drugmakers who sell those products will be watching closely.
- read the article in the International Herald Tribune
- check out the Wall Street Journal story