In 2014, the U.S Food and Drug Administration (FDA) updated its rules about pregnancy and lactation labeling of prescription medication. The new format is intended to provide the most useful information for you and your healthcare provider. Because pregnancy can affect various health problems and chronic conditions, this information helps ensure your health and your baby’s.
Drug labels now include three sections:
- Pregnancy
- Lactation
- Females and Males of Reproductive Potential (information about pregnancy testing, contraception and fertility effects)
New labels will also include information about how to join a pregnancy exposure registry if there is one for the drug. Registries study the effects of medications used by pregnant women. It will take several years for companies to revise the labeling for prescription medications, but new labels will inform you and your healthcare provider so you can choose the best medication to take.
- The Pregnancy subsection (8.1) now includes information about any available pregnancy exposure registry and provides a risk summary, clinical considerations, and supporting data.
- The Nursing Mothers subsection has been renamed Lactation (8.2). It provides information on using the drug while breastfeeding, including levels found in breast milk and potential effects on the infant.
- A new subsection, Females and Males of Reproductive Potential (8.3), includes relevant information on pregnancy testing, contraception recommendations, and drug-related infertility.
For more information about the new FDA labeling requirements, see the following pages on the FDA’s website: