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FDA Updates Pregnancy and Lactation Labeling Requirements

Demetria Ratchford2 years ago

The U.S. Food and Drug Administration (FDA) has created new labeling guidelines concerning the use of prescription drugs and biologics during pregnancy and breastfeeding.

This new rule was published on Wednesday, December 3rd, 2014.

About the FDA Labeling Changes

The FDA’s decision, which has been debated since 2008, is predicted to impact more than 6 million pregnancies in the U.S., specifically those involving women who need to take between three and five prescription drugs during gestration.

According to Reuters,the new rule creates three detailed subsections on the labels of the drugs entitled Pregnancy, Lactation, and Females and Males of the Reproductive Potential. The previous system relied on letter categories (A, B, C, D, and X) to classify the risks of using prescription drugs during pregnancy.

Sandra Kweeder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, supported the new labeling requirements saying, “the letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk.”

Subsection Requirements

The new pregnancy subsection will provide information on dosage and potential risks to the fetus. It will also require manufacturers to provide information on whether the registry collects and maintains data, as well as how pregnant women are affected when using the product.

This information has been recommended in the past, but up until now, it has not been required.

The lactation subsection will provide information about taking the drug while breastfeeding, and the final subsection will include information about pregnancy testing, contraception, and infertility related to the drug.

The changes will be effective by June 30th and will require new approved biologic and drug applications to employ the new format.


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