FDA Steps Up Warnings on Certain Epilepsy Drugs

The FDA has strengthened its warnings on the epilepsy drugs Carbatrol by Shire PLC, Tegretol by Novartis AG, and Equetro by Validus Pharmaceuticals Inc. Carbamazepine is the other name for the drug which is used to treat epilepsy, bipolar disorder, and nerve pain. The drug can cause a rare but potentially life threatening skin disease. The disease manifests itself in toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, and itching. In its statement, the FDA pointed out that those of Asian ancestry should be tested before starting any treatment regimen with carbamazepine since their risk of contracting the skin disease is 10 times higher than in the general population.