FDA warns of epilepsy drug suicide risk

The FDA has issued an alert to healthcare providers regarding an increased suicide risk associated with 11 different antiepileptic drugs, including Neurontin, Lamictal, Lyrica, Trileptal and Topamax. A review of prior clinical trials demonstrated that users of the drug were more likely to commit suicide, attempt suicide or have suicidal thoughts. The FDA alert comes one week after the drug regulators announced a new policy which requires many drug makers to evaluate suicide risks during clinical trials.

>>PRIOR POST (1/30/2008): FDA requires evaluation of suicide risk

The epilepsy drug suicide warning comes after the FDA completed a review of about 200 clinical studies which involved nearly 44,000 individuals taking either an antiepileptic or a placebo. Individuals taking one of the epilepsy medications were found to have about twice the risk of suicidal behavior, which included reports of self-inflicted death, suicide attempts, acts to prepare for suicide and documented thoughts about committing suicide.

The epilepsy drugs which have been linked to an increased suicide risk include:

• Neurontin (gabapentin)
• Lamictal (lamotrigine)
• Lyrica (pregabalin)
• Trileptal (oxcarbazepine)
• Topamax (topiramate)
• Keppra (levetiracetam)
• Gabitril (tiagabine)
• Zonegran (zonisamide)
• Felbatol (felbamate)
• Depakote, Depakene, Depacon (valproate)
• Carbatrol, Equetro, Tegretol (carbamazepine)

Millions of Americans take one of these drugs to treat epilepsy and psychiatric disorders. In addition, Topamax is also approved for treatment of migrains and Lyrica is also approved to treat pain which results from fibromyalgia, shingles and diabetes.

The FDA indicates that healthcare providers should make sure that their patients who are using antiepileptics are aware of the signs of suicide and notify their doctor if any problems develop. Warning signs for suicide could include suicidal thoughts, withdrawal from society, depression or preoccupation with death. With the antiepileptic suicide risks known, patients will also be better able to weigh the benefits provided by the drug against the possible side effects.

According to FDA estimates, antiepileptics’ side effects could result in two more suicides for every 1,000 patients taking one of these drugs when the use is compared to those taking a placebo. However, they have cautioned that individuals currently taking one of the epilepsy drugs should not stop taking their medication without speaking with their physicians. Skipping doses of an antiepileptic could result in seizures.

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