Warnings issued on use of B-MS' antiretrovirals in pregnancy

The US Food and Drug Administration and Bristol-Myers Squibb have warnedhealth care professionals that pregnant women may be at increased risk of fatal lactic acidosis when prescribed the combination of B-MS' antiretroviral drugs Zerit (stavudine) and Videx/Videx EC (didanosine) with other antiretroviral agents.

Although lactic acidosis is a recognized but infrequent side effect of nucleoside analogues, the FDA has recently received three reports of fatalities in pregnant women taking B-MS' drugs in combination with other antiretrovirals. In lactic acidosis, cells of the body are unable to convert food into usable energy and, as a result, excess acid accumulates in the body and organs such as the liver or pancreas may be damaged. Pancreatitis is another recognized side effect of these drugs.

Two of the cases were reported from ongoing clinical trials of an investigational HIV drug, and one was identified through worldwide post marketing surveillance. In addition, the FDA has received several nonfatal reports of lactic acidosis, with and without pancreatitis, occurring in pregnant women receiving only Videx and Zerit. While data have suggested that women may be at increased risk for the development of lactic acidosis and liver toxicity, it is unclear whether pregnancy potentiates these known side effects, said the agency in a Talk Paper.