The U.S. Food and Drug Administration has issued a warning that the hepatitis C drug Incivek, manufactured by Vertex Pharmaceuticals Inc., can cause serious and potentially deadly skin reactions.
Vertex has placed a “black box warning” – the most serious available – on the drug’s label, Reuters reports.
According to the Reuters story, skin rashes were already a known side effect of the drug. The warning came in response to an analysis of data collected since the drug was approved in the United States last year.
That data revealed a number of cases in which the reaction was more severe than those seen in clinical trials of the drug, including some fatal reactions. Incivek is used in combination with interferon and ribavirin.
Stevens-Johnson Syndrome, a condition characterized by extreme skin reactions, can cause the top layer of skin to shed and die. It’s considered a medical emergency, and can be potentially fatal.
The condition is usually an allergic reaction in response to medication, infection or illness.
In May, the U.S. Court of Appeals for the First Circuit sided with a woman previously awarded $21.06 million in damages against the manufacturer of the drug Clinoril, which brought on a case of Stevens Johnson Syndrome that caused her permanent near blindness and skin burns over about 60 percent of her body.
If you or a loved one suffered from Steven Johnson Syndrome, the attorneys at Lopez McHugh can evaluate whether you have a claim. You should consider calling for a free case evaluation today because every state has deadlines for bringing a claim and we can help determine how much time you have.
See the Reuters story here:
See the FDA warning here: