New Hepatitis C Drug Linked to Stevens Johnson Syndrome

FDA Demands Black Box Warning Be Added to Incivek

Following just 18 short months on the market, the FDA ordered Vertex to add a black box warning to Incivek in December 2012. The FDA was compelled to take action after it was made aware of several reports of a serious skin rash linked to the use of Incivek. One of the more significant cases that spurred the FDA into action was that of a patient in Japan who had died from an advanced form of SJS known as Toxic Epidermal Necrolysis (TEN). The patient was unaware of the cause of the rash and continued taking Incivek, which led to the development of the more serious and life-threatening form of the skin condition.

What is Stevens Johnson Syndrome and what are the Symptoms?

Stevens Johnson Syndrome is a serious skin disease that presents itself as a rash at first. It is a severe allergic reaction to medication that the patient may have previously taken and tolerated. As the skin disease progresses, the patient develops blisters and lesions that resemble serious burns. Patients who develop SJS are often treated in the burn unit of a hospital due to its similarity to being severely burned. Other symptoms associated with SJS include:

• Facial Swelling
• Lung Damage
• Skin Pain
• Skin Rash
• Blisters on Skin and Mucous Membranes (Mouth, Nose, Eyes)

After the FDA mandated that a black box warning be added to the Incivek label, it seemed that the benefits of the already questionable medication were being outweighed by the risks. As more cases of SJS and TEN arose, lawsuits began being filed accusing drug companies of failing to adequately warn patients of the potentially life-threatening risk of developing the SJS and TEN from taking the drug.

How to Get Legal Help

If you or someone you know has taken a medication such as Incivek and have developed Stevens Johnson Syndrome or Toxic Epidermal Necrolysis, you may be eligible to receive compensation. To learn more about the current litigation involving SJS and TEN drugs, please visit our Stevens Johnson (SJS) & Toxic Epidermal Necrolysis (TEN) Class Action Lawsuit Investigation web page. Once you submit your information to our team of compensation specialists, you will receive free advice on your individual circumstances and how you can proceed with your lawsuit if you have a case.