Progestational drugs
Executive Summary
FDA is proposing to withdraw the boxed warning in labeling for progestational drug products due to lack of scientific data supporting associations between the drugs and an increased risk of birth defects during the first four months of pregnancy. The agency said that the diversity of the drugs described as progestational and the variety of conditions for which they are administered "make it inappropriate to consider these drugs a single class for labeling purposes." The regulation requiring patient and physician warnings was finalized in 1978You may also be interested in...
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