US changes pregnancy and lactation labeling for drugs

The U.S. Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new rule will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products.
The final rule replaces the current product letter categories used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication (FDA News Release, 3 December 2014).
Click here for the full FDA News Release.
Click here for the final rule.

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