The FDA has issued a new
safety warning for the NNRTI Intelence (etravirine). The text reads:
August 2009
Dear Healthcare Professional:
Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, would like to inform you of an important safety update to the Severe Skin Reactions WARNINGS AND PRECAUTIONS section (5.1) of the INTELENCE (etravirine) tablets prescribing information.
Specifically, the existing Warning and Precaution regarding Severe Skin Reactions has been strengthened to reflect that there have been postmarketing reports of:
• fatality due to toxic epidermal necrolysis
• hypersensitivity reactions, sometimes accompanied by hepatic failure
Additionally, Guidance has been added that INTELENCE should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop. Given the clinical relevance of these adverse reactions, the following information regarding severe skin and hypersensitivity reactions has been included in the INTELENCE Prescribing Information
These kinds of reactions have been seen
with other drugs in this class.
Intelence (aka worst HIV drug name ever) is a second line NNRTI for use in people whose HIV has developed resistance to other NNRTIs, like Sustiva (efavirenz) and Viramune (niravapine).
Intelence has been linked to Stevens-Johnson syndrome: http://www.newsinferno.com/archives/12017#more-12017
It is well known that Intelence has a side effect associated with rashes, itching and in the most serious case necrosis of the dermis. People that have a sensitivity to Bactrim are the most likely to experience Steven Johnson's Syndrome. Been there done that.
What is not well known is that Intelence works fast, and is the perfect prescriptive for people with high viral loads and extremely low (2 digit) T-cell counts. The warnings seem daunting , but what about the black boxes on combivir, zerit, epzicom and the rest?
There is no getting around effects on the liver, as this is the only way humans and animals metabolize food ,chemical substances and get rid of waste. It is just a matter of the better of the evils. Care should be taken with all NNTRI's. Even though the metabolism rate via lab reports portray a steady state. Suspicion is that weight, hydration, fat content should be exclusively taken into consideration when dosing.