Epilepsy Drug Labels to Warn of Suicidal Behavior Risk

June 2008

It has been found that epilepsy drugs can have dangerous side effects in patients. The U.S. Food and Drug Administration (FDA) will soon change the labels of 11 epilepsy drugs to include warnings about the risk of suicidal behavior in those who take the medications.

The FDA analyzed 199 clinical trials involving 43,892 patients and found that there were differences in the behaviors of patients who were given a placebo and patients who were treated with one of the epilepsy drugs. The patients who took the dangerous epilepsy medications displayed a side effect called "suicidality," symptoms of which are behavior and mood changes, suicidal thoughts, and suicide. The drugs that will receive warnings 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

Pfizer, maker of the drug Lyrica, is challenging the FDA’s findings and the agency’s efforts to include warnings on the labels. Drug manufacturers GlaxoSmithKline PLC and Abbott Laboratories also disagree with the FDA’s analysis but said they will cooperate with its decision. The epilepsy medications under investigation are also used to treat non-epilepsy conditions such as chronic pain and Fibromyalgia.