FDA Advisory on Nevirapine

Summary: The FDA summarized existing warnings against ongoing nevirapine treatment in women with a CD4 count over 250, due to a greatly increased risk of serious liver toxicity. (The warnings do not apply to single-dose nevirapine, which does not cause this problem.)

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On January 19, 2005, the FDA issued a public health advisory recommending against starting ongoing nevirapine treatment in women with a CD4 count greater than 250, unless benefits clearly outweigh risks. Both men and women (but especially women) with a high CD4 count are at greater risk of liver toxicity from nevirapine than those with more advanced HIV disease. This warning is not new; the manufacturer Boehringer Ingelheim warned about the same liver risk in February 2004. The new advisory reflects recent changes to the package insert, and also provides an excellent short summary on risks and benefits of nevirapine. The FDA noted that "serious and fatal liver toxicity has not been reported after single doses of nevirapine" (used to prevent mother-to-infant HIV transmission during childbirth) -- and that "symptomatic liver toxicity has not been reported in HIV-infected children, and nevirapine is available in a liquid formulation while many other antiretrovirals are not."

The FDA advisory is at
http://www.fda.gov/cder/drug/advisory/Nevirapine.htm.

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