FDA Issues New Drug Label Rules for Pregnant Women

A new ruling from the Food and Drug Administration will make it easier to understand what prescription medications are safe to take during pregnancy or while breastfeeding.

Spilled Capsules from Prescription Bottle Getty Images: catenarymedia

If you've ever been confused about what medications are safe to take while pregnant or breastfeeding, things just got clearer. The Food and Drug Administration (FDA) just announced that they're changing their guidelines for how prescription medication and biological products (such as vaccines) must be labeled. The decision doesn't impact how over-the-counter medications are marked.

After a series of hearings, focus groups and input from the public, the FDA found that the current drug labeling system for expecting moms and those who are nursing was confusing and overly simplistic. The rule doesn't change what medications are considered safe to take or not, but it makes labeling easier to understand for women and their doctors.

New labeling will be re-organized, with titles and headings changed for clarity. The current system labels drugs in a series of lettered categories (A, B, C, D and X), but that will be replaced with three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential. "Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant-risk considerations," said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, in a release. "The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, fetus and the breastfeeding child."

The rule comes after initially being proposed in May of 2008. It will go into full effect by June 30, 2015. In the meantime, here's what you should know about safely taking meds will pregnant or breastfeeding.

Talk to your doctor.

You should always confab with your physician about starting or stopping any type of medication if you're expecting, according to the Centers for Disease Control (CDC).

Do a little research yourself.

The Organization of Teratology Information Specialists (OTIS) has a trove of information about the risks of taking meds during pregnancy and while you're breastfeeding. You can check out their website Mother to Baby to speak with a counselor or to find more info. Another helpful database is LactMed, which is run by the National Library of Medicine. It contains information about how medications may affect you or your baby and potential alternatives to consider.

Don't forget about your natural remedies.

In addition to talking with your OB-GYN about the drugs you may be taking, the CDC also recommends discussing the herbal and dietary supplements that are part of your routine, too.

You can read more about the FDA's rules for pregnancy medications and their recent decision on their website.

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