FDA Issues New Labeling System on Prescription, Biological Products for Women Who Are Pregnant or Breast-Feeding

Labeling information about using medicines while pregnant or breast-feeding is getting an upgrade, after the FDA published a final rule, setting a new standard.

Labeling information about using medicines while pregnant or breast-feeding is getting an upgrade, after the FDA published a final rule, setting a new standard.

The FDA said the new content and formatting requirements will help communicate relevant information about the risks and benefits of drugs and biological products used during pregnancy and breast-feeding.

The current product letter categories designating the risks of using prescription drugs during pregnancy—A, B, C, D, and X—will be no more. Instead, 3 detailed subsections will describe the risks within real-world context, according to the FDA.

The 3 subsections will be related to pregnancy, lactation, and females and males of reproductive potential. The information will include risks of taking the drug while pregnant or breast-feeding, data supporting the risks, and information to help health care providers make prescribing and counseling decisions, according to 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, in a press release. “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 new labeling rule will take effect June 30, 2015.