FDA Warns of Anti-Epileptic Risks

The U.S. Food and Drug Administration warned doctors about the risk of suicidal thoughts in patients who take anti-epileptic drugs.

An FDA analysis of nearly 200 studies involving 11 anti-epileptic drugs showed that patients taking the drugs have about twice the risk of suicidal thoughts and behaviors, compared with patients receiving placebos, the agency said in a release.

The drugs — carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate and zonisamide — were evaluated in 27,863 patients in drug treatment groups and compared with 16,029 patients in placebo groups. There were four suicides and 105 reports of suicidal thoughts or behaviors among patients in the drug treatment groups. There were no suicides and 35 reports of suicidal thoughts or behaviors in the placebo groups.

The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks.

The FDA said healthcare providers should notify patients, families and caregivers of the potential risk so that patients may be closely observed for notable changes in behavior.