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FDA Plans New Drug Labels for Pregnant Women

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Plans for the Food and Drug Administration’s (FDA) new drug labeling system were announced recently. The new labels, which have been in the works for over a decade, are intended to be easier to understand and provide more information about the possible effects of prescription medicine on pregnant women and their infants.

The current system, says the FDA, is confusing, overly generalized, and does not facilitate the addition of updated information as it becomes available. Under the new labeling system, drugs would be categorized by letters denoting the potential risk it would pose to pregnant women. Furthermore, sections summarizing the effects of the drug on a fetus and breast-fed infants, as well as information regarding the drug’s usage in studies and other clinical considerations, would be added to the labels.

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