FDA Panel Votes Against Epilepsy Drug Warning Labels

July 2008

Jul 11 2008 UPDATE – A U.S. Food and Drug Administration (FDA) advisory panel has voted against adding the agency’s strongest warning to epilepsy drugs. While the FDA wanted the "black box" labels to warn patients about the potential for suicidal behavior, the panel says that studies did not produce enough evidence to merit the severity of a black box warning.

Panel members did recommend sending a medication guide to doctors that would explain the risks of suicide related to epilepsy medicine. They also encouraged doctors to talk to their patients about the risks of suicidal behavior. The FDA often follows the advice of the panel, but is not required to do so.

Jul 10 2008 ORIGINAL ALERT –The dangerous side effects of a class of epilepsy drugs may soon be made clearer to consumers. The U.S. Food and Drug Administration (FDA) wants to issue urgent "black-box" warnings for a group of 11 epilepsy drugs found to increase the risk of suicidality, or suicidal thoughts and behavior, in patients.

Epilepsy medications, such as Pfizer’s Lyrica, are not the only drugs that have these dangerous side effects. In all, there are about 35 drugs that carry warnings for suicide risk. These drugs include antidepressants; smoking-cessation drugs, like Pfizer’s Chantix; and asthma medication, such as Merck & Co.’s Singulair. The epilepsy drugs that now carry "black-box" warnings cautioning consumers about the risk of suicidal thoughts and behavior are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

In the past, the FDA rarely issued suicidality warnings for drugs. This changed in 2004 when the agency was criticized for failing to promptly respond to studies showing a link between suicidality among teens and children to their use of certain medications. Already, six of the 20 best-selling drugs of 2007 carry warnings about suicidality.