FDA to Improve Drug Warning Labels for Pregnant & Breastfeeding Women

If you’re pregnant or breastfeeding, it can be hard to tell whether certain medications are safe for you to take. The current labeling system used to convey risk (A, B, C, D, and X) is confusing, so the Food and Drug Administration (FDA) has announced that they are revamping it, according to a CBS News report.

Beginning next summer, new prescription drugs must clearly state what is known about safe use during pregnancy and breastfeeding. Older drugs will phase in new labels over the next few years.


The new information won’t appear printed on small bottles but will be required on the official drug labeling that doctors are supposed to read prior to prescribing the drug. Additionally, the new rules do not apply to over-the-counter medications even though commonly-used drugs like acetaminophen have been linked to risks such as attention deficit hyperactivity disorder in children.

The FDA says that during the 6 million U.S. pregnancies annually, women take an average of three to five prescription drugs. For some, it’s to control an ongoing condition such as asthma, diabetes, epilepsy, or depression. These conditions can worsen if the women avoid taking their medications because of concerns about their effect on the baby. Others may be on medications for a pregnancy-related infection or to ease the symptoms of morning sickness.

Advocates for more informative labeling have pushed for this change since it was first proposed by the FDA six years ago, and call it a good first step. The effects of many drugs on the reproductive system are still not fully understood.

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