Boehringer-Ingelheim in February sent a letter to U.S. health care professionals about new labeling information regarding safety data for Viramune, a nonnucleoside reverse transcriptase inhibitor.
The company warns that women with CD4-cell counts below 250, including pregnant women, are at a 12-fold greater risk for severe liver toxicity. The greatest risk for several and potentially fatal liver-related complications occur during the first six weeks of Viramune treatment, according to the new labeling information, but some risk is ongoing and patients should be monitored closely for liver problems, often associated with skin rash, during the first 16 weeks of treatment. In some cases, liver damage continued even after the discontinuation of the drug.
Boehringer-Ingelheim officials urge HIV caregivers to counsel all patients that if signs or symptoms of hepatitis, severe skin reactions, or hypersensitivity reactions occur, Viramune treatment should be stopped and medical evaluation sought immediately.