The FDA says confusing labeling is out and now will provide safety data for medication use in pregnancy and breastfeeding in a relevant real-world context.
Last week, the FDA published a final rule that will replace the product letter categories (A, B, C, D, and X) that currently classify the risk of using medications in pregnancy with easier to understand information on pregnancy, lactation, and reproductive potential. These 3 detailed subsections will describe risks in the real-world context of treating pregnant women who need medication. The type of information these 3 new subsections will provide are:
- Pregnancy: information relevant to the using the drug in pregnancy, such as dosing and potential risks to the developing fetus. This subsection 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. (Such information has been previously recommended but not required until now, said the FDA.)
- 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 infertility as it relates to the drug. (This information has been included in labeling, but there was no consistent placement for it until now, said the FDA.)
These changes 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, advised the FDA.
“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,” said Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “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.”
The “Pregnancy” and “Lactation” subsections will also include three subheadings: “risk summary,” “clinical considerations,” and “data.” These subheadings will provide more detailed information regarding, such as human and animal data on the use of the drug and specific adverse reactions of concern for pregnant or breastfeeding women.
Click here for more detailed information on this Final Rule and to comment on an accompanying draft guidance on how this new labeling is to be formatted, including the type of information provided under each heading.