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Vertex drug label to warn on possible fatal rash

[December 20, 2012]  CAMBRIDGE, Mass. (AP) -- The Food and Drug Administration is attaching a black box warning to the Vertex Pharmaceuticals hepatitis C treatment Incivek over a potentially fatal rash.

The FDA says patients taking the pill in combination with two other treatments should stop immediately if they develop a rash that grows worse or comes with symptoms like a fever, diarrhea or mouth sores. Patients taking this drug can develop a rash that covers more than half the body. Vertex Pharmaceuticals Inc. says the drug's labeling had already warned that patients with a serious skin reaction should stop. The new warning is much more prominent on the label. Incivek is taken with the pill ribavirin and interferon, which is given by injection. A black box warning is the most serious form of safety warning. [Associated Press] Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.