FDA updates labeling of drugs for pregnant and lactating women

The US Food and Drug Administration (FDA) recently issued a final rule altering how the labels for physicians on prescription drugs and biological products provide information for pregnant and breastfeeding women. When it goes into effect on June 30, 2015, the current letter grade system of A, B, C, D, and X, which stakeholders found confusing, will be replaced on all drugs approved since 2001.

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The new labeling will require prescribing information for physicians in 3 new subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. The Pregnancy subsection will include information pertaining to the drug’s use, such as dosing and potential risks to the fetus. Information about scientifically acceptable pregnancy exposure registries will also be required. The Lactation subsection will summarize the risks of using a drug during lactation, including information on minimizing drug exposure to a breastfed child, in some situations address . Information about pregnancy testing, contraception, and infertility will fall under the Females and Males of Reproductive Potential subsection; under the current rule, such information is found in a different section of drug labels.

Within the Pregnancy and Lactation subsections, there will be subheadings for risk summary, clinical considerations, and data. Under the subheadings will be information on specific adverse reactions, dose adjustments in pregnancy and postpartum, as well as human and animal data on the drug’s use.

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Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research said “Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

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