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FDA Advisory on Nevirapine

February 28, 2005

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 www.fda.gov/cder/drug/advisory/Nevirapine.htm.


ISSN # 1052-4207

Copyright 2005 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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