FDA mulls sweeping change to drug labels

FDA is considering new, more detailed drug labeling aimed at pregnant and nursing women. The new labels would replace a decades-old system of classifying drugs according to their safety during pregnancy and breastfeeding. Agency officials say the old system is confusing and the categories are very broad. Under the new proposal, labels would offer continuously updated, comprehensive information about the risks to women and their babies, and would include the risks of failing to treat conditions, too. Companies would be required to keep labels up to date; in the past, drugmakers have had to update labels with newly discovered risks, but not when drugs are found to be less risky than once thought. As you know, updating labels is expensive and time-consuming, so non-mandated changes were rarely made. The new scheme is open for comment for 90 days.

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