The US Food and Drug Administration (FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA).) has added a new warning to the package insert for etravirine (Intelence), the most recently approved non-nucleoside (NNRTI)– an important drug classA group of anti-HIV drugs with the same target of action. Anti-HIV drug classes include nucleoside analogue reverse transcriptase inhibitors, protease inhibitors and non-nucleoside analogue reverse transcriptase inhibitors, as well as several others. Combining drugs from three or more classes is the basis of Highly Active Antiretroviral Therapy (HAART). that also includes nevirapine and efavirenz.
The FDA found that one to two percent of people who start the new drug develop a serious rash, particularly within the first six weeks. read more »
