FDA Issues Black Box Warning on Hepatitis C Drug Over Deadly Skin Rashes

The FDA has issued another warning and this one's a doozy.  Apparently, fatal skin rashes have been linked to a popular Hepatitis C drug, called Incivek, made by Vertex Pharmaceuticals. The FDA has issued a "black box warning" on the drug, warning that the medication could potentially be fatal to patients.

This drug had fallen out of favor by doctors because they anticipated newer drugs coming to market.  Additionally, since its approval in 2011, skin rashes have been a persistent problem in patients.  However, the FDA warning has struck a major blow against Vertex Pharmaceutical's Hepatitis C program. 

How Incivek Worked

Incivek was originally approved as a Hepatitis C drug to use in conjunction with an older intravenous drug to treat patients' liver.  When patients develop Hepatitis C, the infection attacks their liver, eventually causing cancer in many cases. The most serious of all strains of Hepatitis, Hepatitis C could literally take decades to show up and rapidly kill patients. 

Incivek was developed in order to be used in combination therapy.  Used in conjunction with such drugs as peginterferon alfa and ribavirin, Incivek was a "direct acting antiviral" which targeted the Hepatitis C virus directly.  In combination, the drugs were intended to eradicate the virus before it multiplied and destroyed the patient's liver.

The Danger of Incivek

Two patients in Japan recently developed toxic epidermal necrolysis, which was a fatal rash.  Having been inundated with reports of skin rashes since its FDA approval, the FDA took these reports seriously and issued a black box warning to patients still using the medication. 

Patients using Incivek are encouraged to talk to their doctors and to seek medical attention if they develop skin rashes.  Should symptoms progress seriously, patients are also encouraged to seek the advice of a skilled product liability attorney to preserve their rights.