Pregnancy and breastfeeding can be an exciting and challenging time for parents, and making informed decisions about medication use during these periods is important. Many medications are safe to use while pregnant or lactating, but some are dangerous. However, finding reliable information about the safety of medications can be overwhelming, especially in regards to the potential risks and benefits for both the parent and the baby.
A few reputable sources for information on medications during pregnancy and lactation are available online:
- The FDA’s Drugs@FDA database provides information on approved drugs, including their pregnancy and lactation labeling.
- The National Library of Medicine’s Drugs and Lactation Database (LactMed) provides information on the effects of medications on breastfeeding infants and on lactation, as well as the medication’s potential risks during pregnancy.
- The Organization of Teratology Information Specialists (OTIS) provides information on medications, chemicals, and other exposures during pregnancy and breastfeeding, and offers a hotline for healthcare providers and patients to obtain information.
Healthcare providers should always be consulted regarding medication use during pregnancy and lactation and should be informed of all medications and supplements being taken. Online sources can be helpful for obtaining general information, but individual circumstances may vary and require specific recommendations from a healthcare provider.
Medications and Lactation
One useful resource for pregnant and breastfeeding parents is the book Hale’s Medications and Mothers’ Milk 2023: A Manual of Lactational Pharmacology by Thomas W. Hale, Ph.D. Considered the worldwide gold standard for lactation support professionals, the book provides evidence-based information on medication use during pregnancy and breastfeeding including the potential risks and benefits for the parent and the baby. The book also includes recommendations for medication use based on the available data.
To find information about a specific medication, parents can search the index or table of contents of the book. Medications and Mothers’ Milk is organized by medication class, making finding information about a particular drug easy. Each medication entry includes information about its known or potential effects on breast milk production and composition as well as the potential risks and benefits for the baby.
Additionally, the book provides a risk category system for medications based on the available data. The categories range from “safest” (category L1) to “contraindicated” (category L5), with several intermediate categories indicating varying levels of risk. These categories can help parents and healthcare providers make informed decisions about medication use during pregnancy and breastfeeding.
- L1: Safest: These medications have been studied extensively in breastfeeding people and have been shown to have no adverse effects on the nursing infant. They are considered safe for use during breastfeeding.
- L2: Safer: These medications have also been studied in breastfeeding people and have been shown to have no adverse effects on the nursing infant. However, there is less data available compared to L1 medications.
- L3: Moderately Safe: These medications have been studied and are considered relatively safe for use during breastfeeding, but there is more limited data on their safety. The benefits of taking the medication during breastfeeding should be weighed against potential risks to the nursing infant.
- L4: Possibly Hazardous: These medications have been associated with adverse effects in the nursing infant in some studies, but the benefits of taking the medication during breastfeeding may outweigh the potential risks. Close monitoring of the infant for any adverse effects is recommended.
- L5: Contraindicated: These medications are considered contraindicated during breastfeeding due to significant risks to the nursing infant. The potential risks to the infant outweigh any benefits to the breastfeeding person. Alternative medications or treatment options should be considered.
While Medications and Mothers’ Milk is a valuable resource, the book is not the only source of information about medication use during pregnancy and breastfeeding. Healthcare providers such as obstetricians and pediatricians can provide personalized recommendations based on the individual situation and medical history of a specific patient.
One of the best sources for medication safety during pregnancy is Briggs Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk by Gerald G. Briggs, BPharm, FCCP, and colleagues. Selected as a Doody’s Core Title for 2022, this comprehensive reference guide provides evidence-based information on the safety of medications during pregnancy and breastfeeding as well as recommendations for their use.
In 2015, the FDA replaced the previous Pregnancy Risk Categories with a new labeling system called the Pregnancy and Lactation Labeling Rule (PLLR), which provides more detailed information about the risks and benefits of medication use during pregnancy and lactation. The PLLR requires drug manufacturers to provide information on the potential risks of a medication to pregnant and breastfeeding people based on available data rather than assigning a fixed category to a medication. The information is presented in three subsections: pregnancy, lactation, and females and males of reproductive potential. The goal of the PLLR is to provide more comprehensive and nuanced information to healthcare providers and patients so that they can make informed decisions about medication use during pregnancy and lactation.
- Pregnancy: This subsection provides information on the potential risks of a medication to a developing fetus during pregnancy based on available data from human and animal studies. It also includes recommendations on whether the medication should be used during pregnancy, and, if so, at what dosage.
- Lactation: This subsection provides information on the potential risks of a medication to a breastfeeding infant, based on available data. It also includes recommendations on whether the medication can be used during lactation, and, if so, whether it is safe for the infant or whether alternative feeding methods should be considered.
- Females and males of reproductive potential: This subsection provides information on the potential effects of a medication on fertility and reproductive function in both females and males. It includes recommendations on contraception use during medication use, as well as information on how long the medication can remain in the body after discontinuation.
Pregnant and breastfeeding people can find reliable information about medication use during times of pregnancy and lactation through resources such as Medications and Mothers’ Milk and Briggs’ Drugs in Pregnancy and Lactation. The sources provide evidence-based information on medication use during pregnancy and breastfeeding including risk categories and recommendations for medication use. Some reputable online sources such as the FDA’s Drugs@FDA database, the National Library of Medicine’s Drugs and Lactation Database (LactMed), and the Organization of Teratology Information Specialists (OTIS) also exist.
Disclaimer: The information provided in this article is not meant to replace the professional medical advice from your health care provider. For detailed information on specific medications or for information on medications not listed, please consult your health care provider.
Briggs, G. G., Freeman, R. K., & Yaffe, S. J. (2021). Briggs’ Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk (12th ed.). Wolters Kluwer.
Hale, T. W., & Rowe, H. E. (2022). Medications and Mother’s Milk: A Manual of Lactational Pharmacology (19th ed.). Springer Publishing Company.
Finding Reliable Information on Medication Use During Pregnancy: https://commons.wikimedia.org/wiki/File:VariousPills.jpg and https://commons.wikimedia.org/wiki/File:People%27s_health_and_wellness_with_drugs(medicine).jpg