Last week, the U.S. Food and Drug Administration (FDA) published a report outlining the new standards for how to present information regarding the safety of medications used during pregnancy and breastfeeding: “The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”  These changes will be put into effect by June 2015.

For many years we have discussed the limitations of the current system used by the FDA to classify the reproductive safety of medications which uses five risk categories (A, B, C, D and X) based on data derived from human and animal studies. While widely used to make decisions regarding the use of medications during pregnancy, many have criticized this system of classification, indicating that this type of drug labeling is often not helpful and, even worse, may be misleading.

The newly designed system would abolish the letters.  Labeling will be required to include the following three subsections. Each must include a summary of the risks of using the drug during pregnancy and lactation. It will also include a discussion of the data supporting the summary and provide relevant information so that health care providers may make more informed treatment decisions:

  • The Pregnancy subsection will provide information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and will require 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. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now.
  • The Lactation subsection will provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.
  • The Females and Males of Reproductive Potential subsection will include information about pregnancy testing, contraception and about infertility as it relates to the drug. This information has been included in labeling, but there was no consistent placement for it until now.

The “Pregnancy” and “Lactation” subsections will also include three subheadings: “Risk Summary,” “Clinical Considerations” and “Data.”  These subheadings will provide more detailed information regarding, for example, human and animal data pertaining to the use of a particular drug, and specific adverse reactions of concern for pregnant or breastfeeding women.

This is good news, and certainly long overdue.  While I am excited about this change, I remain cautious.  Given the amount of information out there – some good, some bad – I wonder how long the pregnancy section of the label will become.  And given how nuanced and complicated this information can be, I worry that clinicians, encumbered by the amount of material to plow through, may be even more reluctant to prescribe medications during pregnancy.



Ruta Nonacs, MD PhD


FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

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