HIV Combination Therapy Caution Issued for Pregnant Women.

2001 FEB 1 - (NewsRx.com) -- The U.S. Food and Drug Administration (FDA) and Bristol Myers Squibb are warning health care professionals that pregnant women may be at increased risk of fatal lactic acidosis when prescribed the combination of the HIV drugs stavudine (Zerit) and didanosine (Videx or Videx EC) with other antiretroviral agents.

Lactic acidosis occurs when cells of the body are unable to convert food into usable energy. As a result, excess acid accumulates in the body and vital organs such as the liver or pancreas may be damaged. Severe lactic acidosis is an infrequent, but well-described complication of the class of HIV drugs known as nucleoside analogues.

Pancreatitis is also a well-described complication of Videx and Zerit. This new warning follows three reported cases of fatal lactic acidosis, with or without pancreatitis, which occurred in pregnant women taking Zerit and Videx in combination with other drugs used to treat HIV. Two of the cases were reported from ongoing clinical trials of an investigational HIV drug, and one was identified through worldwide postmarketing surveillance.

In addition, postmarketing surveillance identified several nonfatal cases of pancreatitis, with and without lactic acidosis or hepatic failure, occurring in pregnant women receiving stavudine plus didanosine. Although 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.