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Medwatch alert: nevirapine can lead to hepatotoxicity in pregnant women with HIV.(Obstetrics)
Certain women taking nevirapine, including those with high CD4 counts or who are pregnant and receiving chronic HIV infection treatment, have a significantly increased risk of hepatotoxicity, Dr. Kirk V. Shepard of Boehringer Ingelheim Pharmaceuticals said in a "Dear Health Care Professional" letter.
In the letter, posted on the Food and Drug Administration's Med-Watch Web site, Dr. Shepard said that the labeling of nevirapine, sold under the brand name Viramune, has been changed to reflect the increased risk revealed by postmarketing surveillance.
Women with CD4 counts greater than 250 cells/[mm.sup.3]--including those who are pregnant and receiving treatment for chronic HIV infection--are at a 12-fold higher risk of severe hepatic events, some of which have been fatal, he wrote.
The greatest risk occurs in the first 6 weeks of nevirapine treatment, but patients are at continued risk after that time, and physicians should monitor them closely for the first 18 weeks of treatment, Dr. Shepard said in the letter. In some ...
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Source: HighBeam Research, Medwatch alert: nevirapine can lead to hepatotoxicity in pregnant...