Intelence Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Warning

By Harvey Kirk
Posted August 31, 2009

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Users of the HIV drug Intelence may face an increased risk of severe and potentially life threatening skin reactions, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Following several reports of users who have died or suffered debilitating problems with Intelence, the warning label has been updated to include stronger warnings that doctors should be closely monitoring patients for signs or symptoms of a skin reaction.

The Stevens-Johnson syndrome lawyers at Saiontz & Kirk, P.A. investigate potential lawsuits throughout the United States for individuals who suffer the serious and potentially fatal skin reaction, which can be caused as a side effect of several different medications. Although the drug’s label has indicated that Intelence side effects may cause skin reactions, the severity of the problems was not adequately conveyed, leading to a strengthening of the warning last week.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are conditions where the skin literally burns from the inside out. The problems usually surface as a rash or blistering of the skin and mouth, with 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

In approximately 5 to 15% of severe Stevens-Johnson syndrome cases, the skin reactions result in death. In more severe cases, where lesions cover about a third of the body, it is referred to as Toxic Epidermal Necrolysis (TEN).

According to a MedWatch alert posted about the potential Intelence side effects:

There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erthema multiforma, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic (liver) failure. Intelenece therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.

INTELENCE STEVENS-JOHNSON SYNDROME LAWSUITS

Intelence (etravirine) is a newer HIV medication that was approved by the FDA in January 2008. It is manufactured by a subsidiary of Johnson & Johnson, Tibotec Therapeutics.

As a result of Johnson & Johnson’s failure to properly warn about the potential Stevens-Johnson syndrome side effects of Intelence when the medication was first introduced, some consumers may have suffered severe skin reactions that could have been avoided.

The lawyers at Saiontz & Kirk, P.A. are evaluating whether users who suffered severe cases of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis may be entitled to compensation through an Intelence lawsuit. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.