The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.
"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 breast-feeding 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."
There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.
The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.
In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.
The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections: