New FDA initiatives focus on drug safety for pregnant and breastfeeding women

New FDA initiatives focus on drug safety for pregnant and breastfeeding women

Women who are pregnant or breastfeeding often need to take prescription medications.

The use of prescription medications during pregnancy and breastfeeding has increased in recent decades. Women who are pregnant or breastfeeding often need to take prescription medications for pregnancy-related conditions, new short-term conditions, or conditions that require ongoing treatment such as asthma, high blood pressure, and depression.

The Centers for Disease Control and Prevention reports that most women take at least one prescription medication at some point during pregnancy. Additionally, more than half of women take a prescription medication in the months following childbirth.

When the U.S. Food and Drug Administration approves a prescription drug for adults, the drug is also approved for pregnant patients. However, information about drug dosage during pregnancy and breastfeeding may not be available. For this and other reasons, it is important to discuss treatment options with your healthcare professional if you are pregnant or breastfeeding.

Pregnancy and breastfeeding label updates

Labeling for more than 2,200 prescription drugs has been updated since June 2015 with the FDA's revised Pregnancy and Breastfeeding labeling format. Improving the quality and quantity of human data is needed to improve information in drug prescribing.

In turn, this information will help healthcare professionals and patients better understand the benefits and risks of prescription medications that women may use during pregnancy and breastfeeding. The revised format that the FDA finalized in the 2014 Pregnancy and Lactation Labeling Rule aims to improve the presentation of pregnancy and breastfeeding-related information.

FDA's Efforts to Increase Pregnancy and Breastfeeding Data

Efforts are underway at the FDA to increase the availability of high-quality data for drugs that women take while pregnant or breastfeeding.

In April 2018, the FDA published guidance on scientific and ethical considerations for enrolling pregnant women in clinical trials. In 2019, the agency published two additional draft guidelines. The first refers to designing studies to collect safety data on pregnancy and infant outcomes, and the second refers to conducting studies to evaluate whether drugs pass into breast milk. The goal of these draft documents, which will be established upon completion, is 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 hosted a workshop on scientific and ethical considerations for including pregnant women in clinical trials. Potential research participants who are pregnant or breastfeeding may not be aware of the options for joining clinical trials.

The FDA Office of Women's Health (OWH) provides a public listing of active pregnancy exposure registries to increase awareness of research participation opportunities for women who may be taking medications or have received a vaccine during pregnancy. Additionally, OWH has a long history of funding research to advance our knowledge of medication use during pregnancy and lactation.

OWH also has educational webinars focused on engaging providers to address knowledge gaps regarding medication use in pregnancy and lactation as well as pregnancy and lactation medication information for healthcare providers, among other topics.

The FDA has also been actively involved in the Federal Task Force on Research Specific to Pregnant Women and Breastfeeding Women. This has recommendations and a plan to increase research to address gaps in knowledge about medication use in pregnancy and breastfeeding.

While these large-scale efforts are underway, we understand that patients want answers now. Deciding which medications to take is a complex and personal decision that you should discuss with your healthcare professional.

If you are pregnant or breastfeeding, talk to your healthcare professional about enrolling in pregnancy safety or breastfeeding studies. With your help and the support of researchers, drug manufacturers and health professionals, the FDA aims to continue improving drug information.

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