Pregnant Women Risk Fatal Side Effect from Antiretroviral Drug Combo

Pregnant women taking a combination of the antiretroviral drugs stavudine and didanosine are at risk for potentially fatal side effects, Reuters/Washington Post reports. The FDA and Bristol-Myers Squibb Co., which manufactures the two drugs, warned Friday that several cases of lactic acidosis, a condition that causes excess acid accumulation in the body and can be deadly in "rare" cases, had been reported in pregnant women taking the medications. While the labels for the two drugs, which are marketed as Zerit and Videx, had previously included "strong" warnings that the medications could cause lactic acidosis in any patient, new evidence reveals that pregnant women have a higher chance of developing the condition. Bristol-Myers spokesperson John Kouten said that the company has "amended" the label to "emphasize" the risk to pregnant women (Reuters/Washington Post, 1/6). Officials were unable to say why the problem seemed to "suddenly arise," but speculated that one cause could be the rising incidence of multidrug regimens for HIV-positive pregnant women, who previously were restricted to one drug during pregnancy (Associated Press, 1/5). The FDA said that three pregnant women died from lactic acidosis while taking the drugs, and four other women had suffered "nonfatal cases" of the condition while on the medications. To inform physicians about the potential risks of the drugs, Bristol-Myers wrote letters to "thousands" of doctors alerting them of the possible side effects (Baltimore Sun, 1/6). The FDA and Bristol-Myers advised pregnant women with HIV/AIDS and their physicians to consider taking Zerit and Videx "only when the benefits outweighed the risks" and urged them to watch for symptoms such as abdominal pain, nausea and vomiting. Lactic acidosis can be reversed if the drug treatment is ceased (Reuters/Washington Post, 1/6). The FDA also has received two reports of pregnant women suffering lactic acidosis while taking a combination of stavudine and the antiretroviral drug lamivudine, or 3TC, and one report from a woman taking didanosine alone. The agency said it is planning to investigate those cases (Associated Press, 1/5).