Incivek to Receive Black Box Warning Concerning Risk of Dangerous Rash

By Joe Messa

Jan 15

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.

Personal Injury Attorneys: Black Box Warning Necessary to Warn Patients of Potentially Fatal Skin Reaction

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.

Personal Injury Attorneys in Philadelphia and New Jersey

The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and defective drug injuries. Our extremely skilled team of personal injury attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective drug, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.


About the Author

Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More