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Simpler Drug Labels for Pregnant and Breastfeeding Mothers

Katlyn Joy |26, February 2015


According to a press release issued December 3, 2014, The Food and Drug Administration has issued new labeling guidelines for drugs used during pregnancy and lactation that replaces the old letter system that went A, B, C, D and X in determining risk level.

This decision will have far-reaching effects. There are over 6 million pregnancies in the US annually, and the average pregnant woman takes 3 to 5 prescription drugs during pregnancy. It's never a simple decision, and the previous labeling practice of the FDA didn't make things any easier.

For some women, the prescriptions they took before pregnancy for chronic conditions such as high blood pressure or asthma have to be continued or another suitable drug found to control a health problem. For other women, acute conditions may arise during or even due to pregnancy, and prescribing information can be difficult to navigate.

Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, "Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child."

The rule finalizes a number of provisions in the rule proposed by the FDA in 2008, and will take effect June 30, 2015. Once this is in effect, all new approved drugs and biological product applications will be required to use the new labeling standards, while those drugs and products previously approved will be allowed to gradually apply the new format.

There are specific types of information found in the three subsections:

Pregnancy: This will contain information relevant to pregnant women including dosing information and risks to the developing fetus. There will also be information on whether or not there is a registry to share information about any side effects experienced by pregnant women using the drug. Previously that was only a recommendation, not a requirement, of the FDA.

Breastfeeding: This will give information on how much medication will pass over to a breastfed child and the potential effects on the child.

Females and Males of Reproductive Potential: This will cover information on pregnancy testing, contraception and infertility and how the medication may impact these areas.

Within each of the three subsets you will see three categories: risk summary, clinical considerations and data.

In December, John C. Jennings, MD, President of the American College of Obstetricians and Gynecologists, ACOG, issued this statement in regards to the FDA changes, "The American College of Obstetricians and Gynecologists applauds the Food and Drug Administration (FDA) for taking needed steps to increase understanding about the effect of prescription medicines on women during pregnancy and lactation. The FDA's updated method of presenting information about both risk and benefit will improve the ability of all physicians to treat their pregnant and breastfeeding patients, as well as women who may become pregnant. It will also help more women to understand and take part in their healthcare decision-making."

"As obstetrician-gynecologists, we understand the importance of keeping women healthy before, during, and after their pregnancies, whether they live with chronic conditions or whether they are confronting new diagnoses. And, we recognize that medications can be vital to maintaining a mother's continued good health when pregnant, a goal of central concern in obstetric care. It is essential that all providers have the information they need to safely, effectively, and reliably treat their female patients. We also want to ensure that medicines will help, and not harm, both mother and child."

"Moreover, ACOG hopes that the inclusion of more information on prescription medicine labeling will provide added incentives for clinical research as well as participation in patient registries, to better capture the impact that prescription medicines have on pregnant and breastfeeding women. It is crucial that healthcare providers have access to as much information as possible, and more research will help lead to better care for women in the future."

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