WHO BI back nevirapine despite fears (Reuters, 20 01 2005)

WHO, Boehringer Back German AIDS Drug Despite Fears

Reuters Jan 20, 2005 Sitaraman Shankar ; James Macharia

On Thursday, the World Health Organization said it continues to back the use of Boehringer Ingelheim’s Viramune (nevirapine), a drug used for preventing mother-to-child HIV transmission and part of a subsidized triple AIDS drug cocktail used as continuous therapy. The announcement came one day after the US Food and Drug Administration issued a warning that nevirapine could cause liver damage.   "We are aware of the toxicity profile [of nevirapine], but at the moment we believe the benefits outweigh any problems," said Charles Gilks, director of WHO’s AIDS treatment and prevention scale-up team.   German drug maker Boehringer said it would continue to offer nevirapine free of charge to poor countries for preventing mother-to-child HIV transmission. "There is no consequence for our donation or for supply of the drug for continuous treatment at reduced prices in developing countries," said a company spokesperson. "We do not expect any major effects on the behavior of doctors or on our sales as a result of the FDA warning," she said, adding that Boehringer was in discussions with European regulators over the drug’s labeling in Europe.   According to FDA, cases of liver damage that produce a rash, fever or other symptoms were more common with nevirapine than with other AIDS drugs. FDA said doctors should weigh risks and benefits before prescribing the drug.   "This is a formalization of something known in the medical community," said Daniel Berman, coordinator of Doctors Without Borders’ Campaign for Access to Essential Medicines. "All of the drugs have side effects and should be monitored at the beginning of treatment. Other drugs have other issues, none of them is perfect."