New Improved Drug Labels for Pregnant Women

U.S. Health officials proposed new changes this week to labels on prescription drugs that would provide more detailed potential health effects for pregnant and breastfeeding women, their fetuses or their newborns. If put into action, the new system created by the Food and Drug Administration would provide physicians and pharmacists with more comprehensive information to guide them in their practices in prescribing medications.

The current systems that relies on letter designations to describe the risks of a drug when taken during pregnancy or breastfeeding, has been deemed incomplete and confusing. "The system of letter categories has led to an inaccurate and overly simplified view of prescribing in pregnancy," Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs, Center for Drug Evaluation and Research, said during the teleconference. "This system also makes it very difficult to update labeling as new information becomes available."

Every year in the United States there are approximately 6 million pregnancies, and pregnant women take an average of three to five prescribed drugs during their pregnancy. Also, women with pre-existing medical conditions such as high blood pressure or asthma may need to use drugs prescribed by their physician to treat their conditions during pregnancy. Under the new labeling proposal, the label would explain the benefits and risks for the mother and her unborn child or her new infant, and how these risks could change over the course of the pregnancy.

The new prescription labels would include three separate sections devoted to breastfeeding and pregnancy. The first section of the label is called the "Fetal Risk Summary," which would describe what is known about the effects of the prescription on the unborn child and whether the risk is based on results of human or animal studies. The next section will be called the "Clinical Considerations," which will include information about the effect associated with the prescription if it were taken before a woman knows that she is pregnant. It would also outline the risks of the disease to the mother and child, information on dosing, and how to address complication if they should occur. The final section will be called "Data," which will describe in detail any available information about the prescriptions use in animal and human studies used in developing the "Fetal Risk Summary."

The section on breastfeeding will use the same format as the pregnancy section and provide information about using the prescription while nursing.

The Food and Drug Administration began work on redesigning the labels on prescription drugs' effects during pregnancy and nursing in 1997. The proposed changes will undergo a process of review with the agency receiving the comments from various stakeholders. Once that review has been completed, the FDA will incorporate all of the comments and come up with the finished version of the new labels. This process could take up to one year to finalize.

Once the new label rules take effect, new prescriptions will have to conform immediately to the revised standard. For prescriptions that are older, the label requirements will be phased in over time. It will probably take several years for all of the prescriptions to comply with the new label standard.

If you would like more information on the prescription drugs and pregnancy, you can visit www.4woman.gov/faq/pregmed.htm.