A black box warning is being put on the drug Incivek, says the U.S. Food and Drug Administration. Incivek, manufactured by Vertex Pharmaceuticals, is used to treat hepatitis C patients and is taken with the pill ribavirin and interferon, which is given by injection. However, the drug is causing a rash that covers more than half the body and could have potentially fatal effects.
The FDA says patients who take Incivek along with two other treatments should stop immediately if a rash develops, worsens or comes with symptoms like a fever, diarrhea or mouth sores. The drug’s label already warns patients of that they should stop using the defective drug if they experience a serious skin reaction; however, the new label will appear in a way that is much more noticeable to consumers.
A black box warning is the most serious form of safety warning. Although skin rashes were already a known side effect of Incivek, an analysis of data since the drug was approved in the United States in 2011 has revealed a number of cases in which the reaction was more severe than those seen in clinical trials of the drug. Some of those cases were fatal causing the need for a black box warning.
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