FDA proposes revisions to pregnancy and breastfeeding drug labeling

The FDA has proposed a revised prescription drug labeling format to better inform patients and healthcare providers about potential drug effects during pregnancy and breastfeeding. The proposed format removes the pregnancy letter categories and will provide the following information: 1) the “Fetal Risk Summary” section which describes what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans; 2) the “Clinical Considerations” section which includes information about the effects of the use of the drug if it is taken before a woman knows she is pregnant; and 3) the “Data” section which would describe in more detail the available data regarding use of the drug in humans and from animal studies.

The lactation section of the labeling would use the same format as the pregnancy section and would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Newly approved drugs would use the new format while previously approved drugs would be phased in gradually to the new format.

For more information visit www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.