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          Pregnant? Breastfeeding? FDA Aims to Improve Drug InformationConsumer Updates Pregnant? Breastfeeding? FDA Aims to Improve Drug Information
  
  	
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              Photo collages of a breastfeeding mom, a bottle of prescription pills, and a pregnant womanEspañol

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

The use of prescription medication 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 reports that most people take at least one prescription medication at some point during pregnancy. In addition, more than half of people take a prescription medication in the months after delivery, according to the CDC.

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

Pregnancy and Breastfeeding Labeling Updates

Labeling for more than 2,200 prescription medications has been updated with the FDA’s revised pregnancy and breastfeeding labeling format since June 2015. Improving the quality and quantity of human data is necessary to enhance information in prescription medication labeling.

In turn, this information helps health care professionals and patients better understand the benefits and risks of prescription medications that people may use during pregnancy and breastfeeding. The revised format, which the FDA finalized in the Pregnancy and Lactation Labeling Rule in 2014, aims to improve 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 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In April 2018, the FDA published a draft guidance on scientific and ethical considerations for including pregnant people in clinical trials.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 draft guidance documents. The first relates to designing studies to collect safety data on pregnancy and infant outcomes, and the second relates to conducting studies to evaluate whether medications get into breast milk. The aim of these draft guidance documents, when finalized, 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 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.

OWH also has educational webinars focused on engaging providers to address knowledge gaps on medication use in pregnancy and lactation, and pregnancy and lactation medication information for health care providers, among others.

The FDA has also been an active participant in the federal Task Force on Research Specific to Pregnant Women and Lactating Women, 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 professional.

If you are pregnant or nursing, talk with your health care professional about whether to enroll in pregnancy safety or breastfeeding studies. With your help and the assistance of researchers, drug manufacturers and health care professionals, the FDA aims to continue improving the information for medications.

                                                                                  Content current as of:
      11/01/2023
              
              
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