Health Risk News 2010: Epilepsy Drugs Get Suicide Risk Warning

While all epilepsy drugs carry a warning about an increased risk of suicidal behavior, it may only be certain newer medications that are connected to the hazard, a study published Monday suggests.
The FDA today announced that it will require makers of epilepsy drugs to add a warning about increased risk of suicidal thoughts and behaviors to the products' prescribing information or labeling.

The warning -- which won't be a "black box" warning -- applies to all antiepileptic medications, including those used to treat psychiatric disorders, migraines, and other conditions, as well as epilepsy. (MEDICINENET.COM)

Those drugs include topiramate (Topamax), tiagabine (Gabitril), levetiracetam (Keppra) and vigabatrin (Sabril).

The findings, published in the journal Neurology, add to a debate about the Food and Drug Administration's decision, in 2008, to require all epilepsy medications to carry a warning about the risk of suicidal behavior.

Monitor Patients

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," Russell Katz, MD, says in an FDA news release. (medicinenet.com)
The FDA said patients and their families should pay close attention to any day-to-day changes in mood, behavior and actions.

These changes can happen very quickly so it is important to be mindful of any sudden differences. Patients and their families should be aware of common warning signs that might be a signal for risk of suicide, including talking or thinking about wanting to hurt themselves or end their lives; withdrawing from friends and family; becoming depressed or having depression get worse; becoming preoccupied with death and dying; and giving away prized possessions. If these or any new and worrisome behaviors occur, patients or their families should contact the responsible healthcare professional immediately.(webmd.com)

Epilepsy Drugs and the FDA

Today's FDA actions are based on the agency's review of 199 clinical trials of 11 epilepsy drugs. The review, which the FDA released in January, showed that patients taking those drugs had almost twice the risk of suicidal behavior or thoughts than patients taking a placebo.

Four patients who were randomly assigned to take one of the epilepsy drugs committed suicide. The biological reasons for the increased risk of suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown, notes the FDA.

Epilepsy itself is linked to a higher-than-average risk of depression and suicide, pointed out Dr. Josemir W. Sander of the University College London in the UK, one of the editorial authors. That, he told Reuters Health in an email, can make it hard to "disentangle" the potential effects of epilepsy medications themselves. (Rueters.com)

The FDA said it would be working with manufacturers of marketed epilepsy drugs to include this new information about suicide risks in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. The FDA is also planning to discuss the suicide data at an upcoming advisory committee meeting.

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