New Prescription Labels for Pregnant Woman and Nursing Mothers
The FDA Reports: As the millions of American women who have experienced pregnancy, delivery and breast-feeding know best, motherhood can be one of the most thrilling, but also anxiety-provoking, periods of their lives. This week, the FDA took a major step to make this memorable time less stressful by helping to make it healthier and safer. The FDA proposed to radically change prescription drug labeling regarding use of prescription medications for women of child-bearing age. We took this step to make the label more informative for doctors, healthcare professionals and patients.
The vast majority of the 6 million American women who get pregnant annually in the United States are in good health and their medical problems, if any, are well addressed. But American expectant mothers take an average of 3-5 drugs during their pregnancy, and pregnant women with chronic conditions such as asthma, high blood pressure, depression or diabetes, may need to take more medications. It is critically important that women and health care professionals have access to the most recent, reliable and clearly described information about the potential effects of these medicines on them and on their developing babies.
New FDA product labeling will do away with the outdated and confusing letter categories that have been used to characterize a drug’s risks when taken during pregnancy. Instead, the prescribing information will add clarity and specificity about what is known and will include such critical facts as: any needed dose adjustment when taken during pregnancy; the drug’s effects during labor and delivery, and possible complications in the new-born baby related to the drug treatment. It will also include data on the drug’s impact on breast-fed babies and on breast-milk production.
The new labeling will assist in counseling women about prescription drugs and biologics so that the balance of the risks and the benefits is clear and it will help them make informed choices about these products.
In addition to exercising our regulatory authority over individual medical products, providing the best scientific information to patients and health care professionals in a format that is easily accessible is part of our mission to protect and promote the health of all Americans.