According to an FDA Alert issued December 16 the US Food and Drug Administration (FDA) will require manufacturers of antiepileptic drugs to carry a warning on their label that the drugs may increase the chances of suicidal thoughts or actions. Also required for each of these drugs will be a risk evaluation and mitigation strategy, including a medication guide for patients.

Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a news release, "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. Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

It listed 21 different medicines sold under various brand and generic names and some of the medicines included in the list are Pfizer Inc's Lyrica and Neurontin, GlaxoSmithKline PLC's Lamictal and Johnson & Johnson's Topamax.

The FDAs decision was based on recommendations from a panel of outside experts who agreed the drugs needed a warning but urged against a strong "black box" that could scare patients from effective treatment. The American Epilepsy Society said, "The risk of suicide possibly associated with (epilepsy drugs) is extremely small compared to the potential danger of leaving patients untreated."

The FDA reviewed 199 clinical trials of 11 antiepileptic drugs and found the risk for suicidal behavior or thought s to be nearly doubled in patients on antiepileptic drugs as compared to patients on a placebo. This amounted to 1 additional case of increased suicide risk for every 500 patients treated with antiepileptic drugs versus a placebo.

In a public health advisory, the FDA said it found people "who took one of the antiepileptic drugs, either alone or as part of a combination, had almost twice the risk of having suicidal thoughts or behaviors compared with patients who did not take one of the drugs."

Pfizer spokesman Jack Cox said the company would work with the FDA to update the drug labels. He said Lyrica and Neurontin "are important medicines that have helped millions of patients with serious conditions."

Glaxo company spokeswoman Sarah Alspach said, the company "remains confident in the overall safety and efficacy profile of Lamictal." Abbott spokeswoman Laureen Cassidy said the company would comply with the request for its drug, Depakote, even though the FDA analysis "did not detect a signal" for the medicine.

While Tricia Geoghegan, a spokeswoman for J&J unit Ortho-McNeil Neurologics Inc. said, Topamax already includes information about suicidal behavior in its prescribing instructions, "We will continue to work with the FDA to make sure any changes they request are in there."

UCB SA will add the warning to its drug Keppra, spokeswoman Andrea Levin said. Another UCB drug, Vimpat, already includes the warning, she said.

According to the 2007 Food and Drug Administration Amendments Act, manufacturers of antiepileptic drugs must submit new labeling to the FDA within 30 days or provide an explanation of their belief that labeling changes are unwarranted.