Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
To the Editor: Two cases were recently reported in THE JOURNAL of health care workers with possible exposure to the human immunodeficiency virus (HIV) who developed adverse reactions after receiving multiple doses of nevirapine, zidovudine, and lamivudine as a postexposure prophylaxis (PEP) regimen.1 - 2 One patient developed fulminant hepatic failure resulting in liver transplant, and the other patient developed rash, eosinophilia, and other systemic symptoms. Both patients have since recovered. The authors believe that nevirapine was responsible for both these adverse reactions, although the precise etiology of these reactions is unknown. Since no clinical trials have been conducted that would assess the risks or establish the efficacy of using nevirapine for PEP, the risks remain undefined. Postexposure prophylaxis is not an approved indication for nevirapine and Boehringer Ingelheim (BI) does not recommend using it for PEP.
Both of the cases were described as acute hypersensitivity reactions. In patients treated with nevirapine, acute hypersensitivity reactions have been reported that manifest as a clinical syndrome consisting of rash associated with constitutional signs and/or symptoms such as fever, arthralgia, and organ involvement. In BI's largest clinical trial to date, which included 1125 nevirapine-treated patients, there were no reports of acute hypersensitivity reactions (BI unpublished data, December 8, 2000). These data have been reported to the US Food and Drug Administration and to the European Agency for the Evaluation of Medical Products.
Worldwide, nevirapine is approved for use in combination with other antiretroviral agents for treatment of HIV infection. The nevirapine label states that severe, life-threatening skin, liver, and hypersensitivity reactions, including fatal cases, have been reported with use of nevirapine. In addition to recently strengthening worldwide labeling regarding these risks, BI previously issued guidelines for management of drug-related rash3 and is now developing guidelines for management of drug-related liver dysfunction.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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