Vertex drug label to warn on possible fatal rash

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

Source: http://hosted2.ap.org/APDEFAULT/bbd825583c8542898e6fa7d440b9febc/Article_2012-12-19-Vertex%20Pharma-Black%20Box%20Warning/id-a67477e6fa974b43be8241aa1da4428a

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