FDA Approves New Suicidality Warning For Epilepsy, Bipolar Meds

The FDA today announced that it has finally approved new warning language for anti-epileptic drugs (anti-seizure drugs, so called mood stabilizers) such as Depakote and Lamictal to reflect suicidality risk. The FDA first raised concerns about the such risks with the drugs in January 2008. Today's announcement also noted that the agency had required "development of a medication guide, to be issued to patients each time the product is dispensed."

There are 11 drugs in the anti-seizure class, some of them multi-billion sellers (Lamictal, Depakote, etc.) due to their twin uses in epilepsy and bipolar disorder. Some pharma companies had apparently pushed back against the FDA and said, in effect, "Not with our drug." The agency now claims:

"The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication."

The risk is supposedly small (less than 1 percent, but spread that out over millions taking these drugs and it sure looks larger) and, according to researchers I've talked with as well as the FDA, is mostly present in people with epilepsy. The risk is also most prevalent during the first six months of taking the drug. Why there's less statistical noise around these drugs for people with bipolar disorder is anyone's guess.