A Drug Safety Warning That Could Harm

July 10, 2008— -- A U.S. advisory panel found a common class of epilepsy drugs carried a suicide risk large enough to be included on labeling, but voted against putting those warnings in a "black box" — the most serious form of label warning issued by the FDA.

Since the FDA proposed the black box warning on Monday, some advocates and epilepsy specialists voiced concern that the black box warning is an overreaction and could deter epileptic patients from taking their much-needed medication.

FDA officials pointed to analysis of 199 different drug studies posted on its Web site, which showed an overall increased risk of suicidal behavior from 0.23 percent for those not using this class of drugs to 0.37 percent for those taking one of the 11 medications, some of which included Lyrica and Lamictal.

"This was a real signal and this signal applied to all the drugs that we studied," said Dr. Russell Katz, director of the Division of Neurology Products, Center for Drug Evaluation and Research at the FDA.

"They voted overwhelmingly that it not be included in a boxed warning," said Katz. "Obviously we take their recommendations very seriously."

Katz added the "signal" of suicidal thoughts and behavior did not appear in several of the drugs studied, but the panel still extended to drugs in the same class out of worry that some drugs would become over-prescribed.

Some doctors who prescribe the anti-seizure drugs questioned if the 0.37 percent risk was enough to warrant a black box warning, and whether the black box warning itself could contribute to unforeseen mental and physical risks.

"Suicide is always a risk in patients with epilepsy, whether taking medication or not," said Philip D. Walson, an adjunct professor of pediatrics at Cincinnati Children's Hospital. "Time will tell whether the association is real or not."

Indeed, epilepsy patients and specialists know the condition can often lead to depression. Social stigmas, potential injuries and the burden of uncontrollable seizures may cause enough stress on their own, even without the side effects of drugs.

Lynn Dann, of Boston, who suffers from epilepsy, has experienced both the benefits and the tolls of epilepsy medications.

"I know because I've been on so many meds that you just have to live through it," said Dann, who has had rashes and problems digesting her medications. Epilepsy has also caused depression along the way.

Dann's epilepsy came on at the age of 30. Her doctors determined that a meningitis infection when she was 10 scarred a part of her brain, which set her up for epilepsy. But it was the stress of law school that "kindled" the seizures, she says.

"I'll feel a pain in my stomach and it will flow through my legs and then zip back up, and then I'll feel like I've eaten nails," Dann said. "There's that feeling and odor of rust."