FDA Proposes to Delete Warning Label on Hormone

Pharmaceutical & Medical Packaging News
July 1999 FDA has proposed that drugs that contain the sex hormone progesterone should no longer carry special labeling that warns pregnant women against their use during the first four months of pregnancy. In a proposed rule published in the April 13, 1999, Federal Register (64 FR:17985–17988), the agency says that based o­n a review of scientific data, there is no need for all progestogens to carry that warning. "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," the proposal states. "This action is intended to provide customers with more-accurate labeling for certain drug products."

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