Fatal risks associated with use of HIV drugs during pregnancy

The Food and Drug Administration (FDA) and Bristol-Myers Squibb Company have warned that two of Bristol-Myers's HIV drugs may be associated with an increased risk of fatality if used during pregnancy.

When taking the two drugs--stavudine and didanosine--together or with other antiretrovirals, pregnant women face an increased risk of suffering fatal lactic acidosis. Lactic acidosis occurs when cells are unable to convert food into usable energy. While the complication is a well-described complication of the HIV drugs, fatal complications have recently been linked to taking the combination. In later stages, excess acid accumulation can lead to failure of the liver and pancreas.

The warnings were issued following the deaths of three pregnant women who had been taking the drug combination, along with other antiretrovirals. All three women contracted lactic acidosis. Two of the women died during pregnancy, and the third, postpartum. Two of the infants involved also died.

In addition to the reported deaths, the FDA has also received several reports of women who claimed to have suffered lactic acidosis while taking both HIV medications. In some cases, the women also developed pancreatic inflammation. These complaints have been mirrored by similar accounts received by Bristol-Myers. The drug manufacturer has also received accounts of women suffering from liver failure after taking the HIV drug combination.

The relationship between lactic acidosis and pregnancy is unclear. Generally, women are at an increased risk for contracting lactic acidosis and suffering liver toxicity. However, people that weigh more than 150 pounds seem to be at a particular risk for lactic acidosis and liver inflammation, and in particular, women in this group seem to be at a particular risk.

The symptoms associated with lactic acidosis may arise abruptly and without warning. Therefore, the FDA and Bristol-Myers are recommending that women only take the combination of drugs where the benefits clearly outweigh the risks, such as in cases where all other treatment options have been explored unsuccessfully.

Stavudine is sold under the trade name Zerit, and didanosine is sold under the trade name Videx EC.

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