Wednesday, June 04, 2008

FDA's Next Steps on Epilepsy Drugs and Suicide

Man, we hate to say we told you so.

Today, the Wall Street Journal reported that several manufacturers of anti-epileptic medications met with FDA officials in New York to try and convince the agency not to add warnings to product labeling on an increased risk if suicidality.

During the closed-door meeting, three drug manufacturers—GlaxoSmithKline (which markets the epilepsy drug Lamictal), Pfizer (Neurontin and Lyrica) and UCB (Keppra)—made presentations to FDA, according to the Journal. Despite best efforts, the companies left the meeting “convinced” that the agency would revise labeling.

That was probably a foregone conclusion. Given that FDA believes that a two-fold increased risk of suicidality is a problem with all 11 anti-epilepsy medications, the agency is quite likely to ask for class labeling as a result. Indeed, FDA already issued a MedWatch alert on the risk in January; class labeling was just a matter of time.

But that won’t be all that FDA will be asking of drug sponsors. The agency is also interested in asking sponsors of new anti-epileptic medications to use the prospective Columbia Suicide Severity Rating Scale (C-SSRS) to predict whether the investigational drug might carry a higher risk of suicidality.

As Office of New Drugs director John Jenkins said in an interview in the April issue of The RPM Report, “it wouldn’t be illogical for us, now that we have observed this finding, to ask future anti-epileptic trials to include a C-SSRS-type of rating scale.” FDA already routinely asks antidepressant manufacturers to use a prospective scale like C-SSRS, and has started asking manufacturers of certain centrally-acting weight loss products (read: Merck’s taranabant) to use it as well.

Finding a link to psychiatric adverse events isn’t usually good for product sales—look no further than Pfizer’s smoking cessation drug Chantix (and our earlier blog post). But over the long term, manufacturers would be wise to take a cautious approach to psychiatric drug safety. FDA certainly is.

No comments: