Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to taking medications safely.
To assist physicians and other prescribers in their discussions with patients, the FDA Medicine and Pregnancy website provides valuable patient education resources to facilitate the conversation. For example, the “Medicine and Pregnancy” fact sheet provides four simple tips to patients when talking to their healthcare providers about using prescription and over-the-counter medicines. The site also includes information on food safety, breast pumps, and tips for new moms, as well as useful tips for clinicians, including:
- Emphasize that patients should always talk to their healthcare provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
- Encourage patients to check drug labels and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
- Assist pregnant patients with changing medications as needed.
- Advise pregnant women if they need to take more or less of their medicines.
- Advise patients about medicines that can and cannot be used when they start breastfeeding.|
- Encourage patients to talk about any problems they have with their medicine.
- Tell the FDA about any serious problems your pregnant patients have had after taking a medicine. What to Report to FDA:
Serious side effects
Product quality problems
Product use errors
- Report problems with these products to the FDA:
Blood products and other biologics (except vaccines)
The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule (PLLR). The PLLR requires changes to the content and format for information presented in prescription drug labeling. The changes were implemented to assist healthcare providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers.
Pregnancy Exposure Registries
Clinicians should encourage patients to enroll in a pregnancy exposure registry, if applicable. The FDA website includes a comprehensive list of these registries. Pregnancy registries collect information on pregnancy outcomes in women who are already taking medication. Observational studies of pregnancy exposure registries can help improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with registries can also help physicians with making medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.
The FDA offers a variety of free resources for pregnant women, including downloadable infographics, a Medicines Record Keeper brochure in English, Spanish, and other languages, medicine booklets, videos, fact sheets, tips, and more.
Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect them and their babies. The FDA pregnancy website can help make a woman’s pregnancy happier and healthier.
Readings & Resources (click to view)
FDA. Medicine and pregnancy. Available at www.fda.gov/forconsumers/byaudience/forwomen/ucm118567.htm.