FDA says two AIDS drugs should not be used in pregnant women

By Christy Feig
CNN Medical Correspondent

WASHINGTON (CNN) -- The deaths of three pregnant women prompted the U.S. Food and Drug Administration and Bristol-Myers Squibb Friday to warn doctors about using a combination of two anti-HIV drugs in pregnant women.

The drugs, stavudine (or d4T) and didanosine (or ddI), may increase the risk of fatal lactic acidosis in pregnant women, especially when combined with other medications.

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Lactic acidosis is a condition that occurs when cells are unable to convert food into usable energy. Excess acid accumulates in the body and can damage organs like the liver or pancreas. Lactic acidosis is a known side effect to some anti-HIV drugs.

The FDA said it has received several reports of non-fatal lactic acidosis in pregnant women who were only taking the two drugs. 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 exacerbates the drugs' side effects.

The drug company sent a warning letter to health professionals Friday, saying the combination of the two drugs should only be prescribed for pregnant women when the benefit clearly outweighs the risk, for instance, when a woman has exhausted all other treatment options.

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FDA Talk Paper on stavudine and didanosine for pregnant women
Avert.org: HIV, AIDS and Pregnancy
March of Dimes: HIV and AIDS in Pregnancy
StorkNet: HIV/AIDS in Pregnancy
Project Inform: Mitochondrial Damage and Lactic Acidosis
Bristol-Myers Squibb

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