FDA Revises Prescription Labels for Pregnant & Breastfeeding Women


Out with the old and in with the new. The United States Food and Drug Administration (FDA) is overhauling the outdated, five-letter system used to inform breastfeeding and pregnancy women about medicine precautions.

The current labeling system designates each prescription or biologic medication as either a category A, B, C, D, X or N substance. Each category warns of possible risks to a woman trying to get pregnant, is pregnant or breastfeeding. However, the overly simplistic system is not well understood at a glance.

Over the next several years, expect to see new labeling that focuses more on lactation and pregnancy warnings, according to the FDA. Information will include:

  • whether or not the medication is secreted into breast milk
  • how much medication transfers to breast milk
  • the effects the medication can have on a fetus or baby

The new labeling will also focus on fertility effects for men and women. The details will include how medication can affect pregnancy testing, birth control effectiveness and the ability to conceive.

One word of caution: The new FDA labeling will not be applied to over-the-counter medications, supplements or herbal remedies. If you’re trying to conceive, are already pregnant or breastfeeding, talk with your gynecologist or pediatrician about how these medications may affect you and your baby.

With increasingly more people taking medications for everything from asthma to depression, the need for more detailed, easy-to-understand labeling is essential. The new information will make it simpler for doctors to find the right mix of prescriptions to keep everyone in the family healthy.