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Bristol-Myers Squibb Zerit and Videx

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Black-box warnings and the "Warnings" and "Precautions" sections of labeling for Zerit (stavudine), Videx (didanosine) and Videx EC will be strengthened following reports of fatal lactic acidosis in the infants of pregnant women taking a combination of Videx and Zerit. "Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other retroviral agents," the revised black-box warning says. "The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit outweighs the risk
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