FDA mandates drug label revisions, black box warnings

May 7, 2009

The FDA has issued new labeling requirements for anti-seizure drugs due to potential increased risk of suicidal behaviors.

The Food and Drug Administration (FDA) has issued new labeling requirements for anti-seizure drugs due to potential increased risk of suicidal behaviors, according to FDA MedWatch.

FDA is also mandating that a medication guide be distributed to patients who take the drugs. All approved anti-epileptic drugs, minus those indicated for short-term use, fall under the new FDA revised labeling rules. The new requirements follow findings from placebo-controlled clinical studies of 11 drugs that are used for epilepsy and psychiatric disorders.

In a statement, FDA noted, "The increased risk of suicidal thoughts or behavior was generally consistent among the 11 drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all anti-epileptic drugs used for any indication."

Drugs included in the studies were: felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); levetiracetam (Keppra); oxcarbazepine (Trileptal); pregabalin HCl (Lyrica); tiagabine (Gabitril); topiramate (Topamax); zonisamide (Zonegran); carbamazepine (Carbatrol, Equetro, Tegretol, and Tegretol XR); and valproate (Depakote, Depakote ER, Depakene, and Depacon).

In other FDA news, the agency is enforcing serious warnings on two testosterone gel products, following news reports of children who experienced inappropriate genitalia enlargement or became aggressive due to exposure to the treatments. Manufacturers of AndroGel 1% and Testim 1% must now provide black-box warnings on labels to warn of side effects to children if they are even indirectly exposed to the products.