Progestational drug products for human use; requirements for labeling directed to the patient. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is revoking its regulation requiring patient labeling for progestational drug products. Patient labeling had been required to inform patients of an increased risk of birth defects reported to be associated with the use of these drugs during the first 4 months of pregnancy. FDA concluded that, based on a review of the scientific data, such labeling for all progestogens is not warranted. In addition, the diversity of drugs that can be described as progestational and the diversity of conditions these drugs may be used to treat make it inappropriate to consider these drugs a single class for labeling purposes. This action is intended to provide consumers with more appropriate labeling for certain drug products.