FDA changes pregnancy, lactation information within drug labeling

The FDA recently issued a final rule to change pregnancy and lactation labeling information for prescription drug and biological products.

The final rule requires the removal of pregnancy categories A, B, C, D and X from all human prescription drug and biological product labeling.

New subsections will be used under this final rule, including:

a pregnancy subsection that includes dosing information, potential risks to the developing fetus, and will designate if there is a registry of data on how pregnant women are affected by the drug or biological product;
a lactation subsection that provides guidance on use of the drug while breast-feeding, including the amount of drug in breast milk and potential effects for a child who is breast-fed;
a females and males reproductive potential subsection that explains how the drug interacts with pregnancy testing, contraception and infertility

The pregnancy and lactation subsections will include three subheadings titled risk summary, clinical considerations and data.

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” Sandra Kweder, MD, deputy director of the FDA’s Office of New Drugs, said in a press release. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified 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 breast-feeding child.”

The final rule becomes effective June 30, 2015.