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SAN FRANCISCO -- Pregnant women on antiretroviral therapy for HIV infection should be monitored frequently for hepatic complications, investigators from the Food and Drug Administration suggested in a poster presentation at the 11th Conference on Retroviruses and Opportunistic Infections.
Although use of antiretrovirals has improved maternal health and lowered the risk of viral transmission to the fetus, 10 HIV-positive pregnant women have died from hepatic failure, 6 of them in 2003 alone, according to data from the FDA's Adverse Event Reporting System. The data were collected beginning in 1987.
The women died during pregnancy or within 1 week of delivery, said Dr. Melisse Baylor of the FDA's division of antiretroviral drug products, Rockville, Md.
Severe hepatotoxicity occurred in patients on zidovudine (ZDV), lamivudine (3TC), or nevirapine (NVP) and with antiretroviral regimens containing didanosine (ddI) or stavudine ...