FDA: Pregnancy Categories to be Replaced with More Detailed Information

The Food and Drug Administration (FDA) has issued a final rule to standardize how information is presented in labeling of prescription drugs and biologics regarding the use of medicines during pregnancy and breastfeeding.

The final rule removes the current letter categories (eg, A, B, C, D, X) and replaces it with three subsections that detail the risks within the context of caring for pregnant women who may need medication. The three subsections will be titled "Pregnancy," "Lactation," and "Females and males of Reproductive Potential." These subsections are required to include a summary of the risks of using a drug during pregnancy and breastfeeding, as well as a discussion supporting the summary and information to assist healthcare providers in their prescribing and counseling decisions.

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Specifically, the subsections will include:

  • Pregnancy: information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug or biological product.
  • Lactation: information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.
  • Females and Males of Reproductive Potential: information about pregnancy testing, contraception and about infertility.

The "Pregnancy" and "Lactation" subsections will also include three subheadings: "risk summary," "clinical considerations," and "data," to provide more detailed information.

The final Pregnancy and Lactation Labeling Rule (PLLR) will be in effect as of June 30, 2015.

For more information visit FDA.gov.

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