Serious Health Risks with Antiepileptic Drugs

FDA issued new information on Jan. 31, 2008, to alert health care professionals about an increased risk of suicidal thoughts and behaviors in patients who take medications called antiepileptics. Such drugs treat epilepsy, bipolar disorder, migraine headaches, and other conditions.

FDA studied suicidality reports from 11 antiepileptic drug studies and found that patients taking antiepileptics have about twice the risk of suicidal thoughts and behaviors, compared with patients receiving an inactive substance (placebo). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.

FDA recommends that

• Patients currently taking antiepileptic medicines not make any changes without first talking to their health care providers.
• Health care providers notify patients, their families, and caregivers of the potential for an increase in the risk of suicidality, so that patients can be closely observed for notable behavior changes.

Although only the following drugs were part of the analysis, FDA expects that all medications in the antiepileptic class share the increased risk of suicidality:

• 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)

The agency will work with manufacturers of marketed antiepileptic drugs to include this new information in the labeling of these products. FDA anticipates that labeling changes will be applied broadly to the entire class of drugs.