Chantix Stevens-Johnson Syndrome Side Effects Added to Warning Label

Since the Chantix black box warning was announced earlier this week, the focus has been on the increased risk of suicides and other behavior changes. However, Pfizer also quietly added new information to less prominent areas of the label about reports of serious skin reactions, such as Stevens-Johnson Syndrome, which our Chantix lawyers have been investigating for over a year.

>>PRIOR POST (6/11/2008): Chantix Stevens-Johnson Syndrome Side Effects
Added to Lawsuit Investigations

Stevens-Johnson Syndrome, commonly referred to as SJS, is a rare skin reaction that can occur as a side effect of several medications. It results in severe rashes and blistering of the skin and mouth, where the skin literally burns from the inside out. It often requires treatment in a hospital intensive care unit (ICU) or burn care unit, and it can result in death. If the top layer of the skin detaches from the lower layers and lesions cover more than 30% of the body, SJS is often diagnosed as Toxic Epidermal Necrolysis (TEN) or Lyell’s Syndrome.

Concerns about potential Chantix and Stevens-Johnson Syndrome arose after an independent report by the Institute for Safe Medication Practices examined FDA adverse event reports involving Chantix from the 4th quarter of 2007. Several users of the stop smoking drug reported suffering severe and debilitating skin reactions consistent with Stevens-Johnson Syndrome.

Last month, the potential Chantix SJS skin reactions were noted on a quarterly report by the FDA of drugs they were investigating for potential health risks that emerged between October 2008 and December 2008. The FDA indicated that Chantix was showing potential signals for “serious skin reactions,” as well as other problems.

According to a press release issued by Pfizer on July 1, 2009, in addition to the boxed warning about behavior changes and suicidal tendencies, the following new information was added to the Warnings and Precautions sections of the Chantix warning label:

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

CHANTIX STEVENS-JOHNSON SYNDROME (SJS) LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential Stevens-Syndrome lawsuits for individuals who have been diagnosed with the severe skin reaction, which could involve symptoms like:

• Rash, blisters or red spots on the skin
• Blisters in the mouth, eyes, ears, nose or genital area
• Swelling of the eyelids
• Fever or flu-like symptoms

Potential Chantix lawsuits are also being reviewed for suicides and suicide attempts, new on-set diabetes and catastrophic injuries from a fall or accident caused by seizures, black-outs, vision disturbances or other sudden problems.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.