New Rxing info for carbamazepine agreed

17 December 2007

The US Food and Drug Administration says that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the products' labeling a recommendation that, before starting therapy, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol (by Shire Pharmaceuticals), Equetro (by Validus Pharmaceuticals) and Tegretol (by Novartis).

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, the FDA's Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer and Acting Director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin rections," she added.

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