Pregnant? Breastfeeding? FDA Aims to Improve Drug Information
People who are pregnant or breastfeeding often need to take prescription medications.
Prescription-medication use during pregnancy and while breastfeeding has increased over the past several decades. People who are pregnant or breastfeeding often need to take prescription medications for pregnancy-related conditions, new short-term conditions, or medical conditions that require ongoing treatment, such as asthma, high blood pressure, and depression.
The Centers for Disease Control and Prevention (CDC) report that most people take at least one prescription medication during pregnancy. In addition, more than half of individuals take a prescription medication in the months after delivery, according to the CDC.
When a prescription medication is approved by the U.S. Food and Drug Administration for adults, it is also approved for pregnant patients. But information about medication dosing during pregnancy and breastfeeding is often not available. For that and other reasons, it is important to discuss treatment options with your health care provider if you are pregnant or breastfeeding.
Pregnancy and Breastfeeding Labeling Updates
Labeling for more than 1,800 prescription medications has been updated with the FDA’s revised pregnancy and breastfeeding labeling format since June 2015. The revised format aims to improve presentation of pregnancy and breastfeeding-related information.
The FDA’s review of the information, which was done as part of the labeling update, uncovered the lack of high-quality human data on the use of prescription medications during pregnancy and breastfeeding. In fact, labeling for new prescription drugs doesn’t generally include any human data about the safety of the medication when used during pregnancy or nursing. Instead, it includes data only from animal studies.
Improving the quality and quantity of human data is necessary to enhance information in prescription medication labeling. In turn, this information helps health care providers and patients better understand the benefits and risks of prescription medications that people may use during pregnancy and breastfeeding.
FDA’s Efforts to Increase Pregnancy and Breastfeeding Data
Efforts are underway at the FDA to increase the availability of high-quality data for medications people take while they are pregnant or breastfeeding.
In April 2018, the FDA published a draft guidance on scientific and ethical considerations for including pregnant people in clinical trials. In 2019, the agency published two other guidance documents to help advise drug manufacturers and researchers on how to design studies to collect safety data on pregnancy and infant outcomes, and whether medications get into breast milk. Those guidance documents aim to improve the consistency and quality of pregnancy safety and breastfeeding studies.
In February 2021, the FDA and the Duke-Margolis Center for Health Policy held a workshop on scientific and ethical considerations for including pregnant people in clinical trials. Potential research participants who are pregnant or breastfeeding may not be aware of opportunities to join clinical trials.
The FDA’s Office of Women’s Health (OWH) provides a public listing of active pregnancy exposure registries to bring awareness of opportunities to participate in research for people who may be taking medications or received a vaccine while pregnant. In addition, OWH has a long history of funding research to expand our knowledge on medication use during pregnancy and lactation.
The FDA has also been an active participant in the federal Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), which has developed recommendations and a plan to increase research to address gaps in knowledge on medication use in pregnancy and breastfeeding.
While these large-scale efforts are underway, we understand that patients want answers now. Deciding which medication to take is a complex and personal decision that you should discuss with your health care provider.
If you are pregnant or nursing, talk with your health care provider about whether to enroll in pregnancy safety or breastfeeding studies. With your help and the assistance of researchers, drug manufacturers, and health care providers, the FDA aims to continue improving the information for medications.