Chantix® & Stevens-Johnson Syndrome (SJS)

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Among the Serious Side Effects Reported from Chantix®(varenicline) use is Stevens-Johnson Syndrome (SJS)

What’s the problem?

A serious skin condition, Stevens-Johnson Syndrome (SJS) can be life-threatening. Cell death causes the outermost layer of the skin (epidermis) to separate from the dermis (skin beneath the epidermis that consists of connective tissue). The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.

In addition to heart problems, diabetes and depression, Chantix users have also reported experiencing Stevens Johnson Syndrome (SJS). In fact, as of December 2007, nearly 1,000 patients reported to the FDA that they had developed SJS after taking Chantix.

The connection between Chantix and the risk of SJS was highlighted in a study conducted by the Institute for Safe Medication Practices (ISMP), which used a combination of FDA adverse event reports and pharmaceutical industry Standardized Medical Queries (SMQ) to gather its data:

  • In the 4th quarter of 2007, Chantix accounted for 998 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.
  • Among the series injuries reported were moderate and severe skin reactions. The FDA notes 338 serious events including hives or swelling of the tongue, face, eyes, lips, and other areas. An additional 65 reports of severe side effects included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.

The results are even more worrisome because FDA adverse event reporting is voluntary for consumers and health professionals, and as a result it is estimated that only 1 to 10 percent of serious adverse events are reported.

Chantix Stevens-Johnson Syndrome Symptoms

Make sure you are familiar with the symptoms of Stevens-Johnson Syndrome (and other Chantix complications), as this awareness can help you identify developing health problems between doctor visits. Seek immediate medical treatment if you begin experiencing SJS symptoms, which include (but are not limited to):

  • fever, hives
  • blisters, particularly around the eyes, nose and mouth
  • burning sensation in the eyes
  • cough, sore throat
  • facial and/or tongue swelling
  • red or purple skin rashes
  • skin shedding
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