CAMBRIDGE, Mass. (December 19, 2012)—The U.S. Food and Drug Administration is attaching a black box warning to the Vertex Pharmaceuticals hepatitis C treatment Incivek because of 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 such as a fever, diarrhea or mouth sores.
Patients taking this drug can develop a rash that covers more than half the body.
Vertex Pharmaceuticals Inc. said 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.
Viewers with disabilities can get assistance accessing this station's FCC Public Inspection File by contacting the station with the information listed below. Questions or concerns relating to the accessibility of the FCC's online public file system should be directed to the FCC at 888-225-5322, 888-835-5322 (TTY), or firstname.lastname@example.org.