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FDA Wants New Labeling Rules To Protect Pregnant, Nursing Women

With six million pregnancies per year, problems can add up fast

May 29, 2008

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Some prescription medicines are fine for most women, but might cause serious problems if taken by women who are pregnant or nursing. The U.S. Food and Drug Administration has proposed new labeling rules it says will help doctors know why it is safe to prescribe medicine for women.

The proposed labeling changes 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.

While physicians are the primary recipients of this information, the FDA says the labeling rules are sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides.

"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.

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