FDA proposes major revisions to drug labeling

Rockville, Md.鈥擳he U.S. Food and Drug Administration announced May 28 that it is calling for major revisions to the physician labeling for prescription drugs (package inserts) in order to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The new rule, which would include biological products, would give health care professionals more comprehensive information for making prescribing decisions. It would also make it easier for physicians when counseling women who are pregnant, breastfeeding or of childbearing age about using prescription medications, according to an FDA release.

“With this proposal, FDA’s goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breastfeeding infants will benefit,” said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. “This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well-being for women.”

The FDA estimates that of the six million pregnancies each year, women take an average of three to five prescription drugs during pregnancy not including medicines for pre-existing conditions such as asthma or high blood pressure.

Under the proposal, the FDA said drug labeling would explain the potential benefits and risks for the mother and the fetus and how these risks may change during the course of pregnancy. Additionally, the proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling.

The release went on to say that the newly designed format for the pregnancy section of the labeling would have three sections:

• The “Fetal Risk Summary” section would describe 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.
• The “Clinical Considerations” section would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information and tell how to address complications.
• The “Data” section would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

For more information, visit: www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm.聽