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Three cases of fatal lactic acidosis have been reported in pregnant women treated throughout pregnancy with the combination of stavudine (Zerit) and didanosine (Videx). Based on these cases, Bristol-Myers Squibb (BMS) asks that caution be used when combining stavudine and didanosine during pregnancy. The combination is recommended only if the potential benefit clearly outweighs the potential risk, such as when there are few remaining treatment options. The three reported cases occurred in women who were either pregnant or postpartum, who were taking stavudine, didanosine, and other antiretroviral agents in combination. Two women had pancreatitis; the third did not. Two of the fatalities occurred during clinical trials; the third was reported via postmarketing surveillance performed worldwide. Postmarketing surveillance has also revealed several nonfatal cases of pancreatitis, with and without lactic acidosis or hepatic failure in pregnant women taking both stavudine and didanosine.
The Boxed Warning, Warnings, and Precautions sections of the drug labels already stated a risk of lactic acidosis, but BMS has broadened those sections to reflect the cases recently reported. A copy of the BMS letter to health professionals can be found at www.fda.gov/medwatch/safety/2001/safety01.htm#zerit.