INTELENCE COMPLICATIONS

Pritzker Olsen Law Firm is representing several clients who have suffered injury from medical products. If you are interested in a free consultation, please contact Pritzker Olsen toll free at 1-888-377-8900 or complete the firm's online-consultation form. We are not paid unless you win.

Urgent Drug Warning: INTELENCE, a drug used for the treatment of HIV-1 infection, may cause life-threatening toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure (liver failure).

In response to post-marketing reports of INTELENCE-associated cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hepatic failure, Tibotec Therapeutics, manufacturer of INTELENCE has revised the “Warnings and Precautions” section of the prescribing information for INTELENCE (etravirine):

5 WARNINGS AND PRECAUTIONS
5.1 Severe Skin and Hypersensitivity Reactions
Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving INTELENCE™ compared to 0.2% of placebo subjects. A total of 2% of HIV-1-infected subjects receiving INTELENCE™ discontinued from Phase 3 trials due to rash. Rash occurred most commonly during the first 6 weeks of therapy.

Discontinue INTELENCE™ immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia). Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping INTELENCE™ treatment after the onset of severe rash may result in a life-threatening reaction.

To contact the firm for a free consultation, please call toll-free at 1-888-377-8900 or submit the firm's online form for a free consultation.

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