Epilepsy Drugs Get New Warnings

December 2007

New warning labels will be issued for drugs used to treat epilepsy, according to the Food and Drug Administration (FDA). Brand name epilepsy drugs such as Carbatrol, Tegretol, and Equetro may lead to a rare skin disorder, warranting a change in the current warning on the drugs.

Carbatrol, Tegretol, and Equetro are known generically as carbamazepine. The drugs are used to treat epilepsy, as well as bipolar disorder and nerve pain. Side effects include skin conditions such as epidermal necrolysis and Stevens-Johnson syndrome, which may result in blisters, fever, itching, and lesions.

The FDA has announced that drugs made with carbamazepine will now prominently feature this information in pre-existing black box labels warnings about the risk of anemia. The drugs will also feature warnings specific to people of Asian ancestry, where the occurrence of the skin condition side effects are estimated to be 10 times greater.