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COPYRIGHT 2004 International Medical News Group
In the wake of three deaths in women who had taken mifepristone to terminate an early pregnancy, the Food and Drug Administration has called on the manufacturer to strengthen the warnings in the drug's labeling, including the black box warning.
The warnings about missed ectopic pregnancy, bleeding, and sepsis have been in the product literature already, but will get more prominence, said Steven Galson, M.D., acting director for the Center for Drug Evaluation and Research at FDA, in a teleconference announcing the changes.
The revised black box section of the prescribing information will...
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