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Nevirapine (Viramune®) Strengthens Warning on Liver, Skin Toxicities

November 17, 2000

On November 9 Boehringer Ingelheim Roxane Laboratories notified medical professionals that the FDA-required labeling for its drug nevirapine had strengthened its warnings about risks of liver and other toxicities, due to reported cases of serious or fatal reactions to the drug.

All future U.S. prescriptions and refills of nevirapine should come with a new patient package insert, which will tell patients what they most need to know to use the drug safely -- including a description of symptoms which should lead to an immediate call to one's physician, who may decide to stop the drug permanently.

The first twelve weeks on nevirapine is especially critical, as about two thirds of the reactions have happened in that period. Also, the letter recommends that prednisone should not to be used to prevent nevirapine-associated rash, as a clinical trial found that this made the problem worse.

The full text of the letter to medical professionals is on the FDA Web site at: http://www.fda.gov/medwatch/safety/2000/virahp.pdf

Some of the warnings:


Comment

Nothing in this letter addresses use of a single dose of nevirapine to prevent mother-to-infant transmission of HIV; these toxicities occurred in patients taking multiple doses. Nor does the warning imply that the risk with this drug is greater than with other antiretrovirals. If any antiretroviral combination had a significantly better safety and efficacy profile than the alternatives, then those alternatives would not be used.

This warning underlines the need for care in using all anti-HIV drugs, the need for the development of better drugs, and the need for more creative research into why the various toxicities occur, how to predict which patients are most vulnerable to which drugs, and better ways to prevent the problems from developing.



ISSN # 1052-4207

Copyright 2000 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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