Drug Labels to Clarify Risks During Pregnancy and Lactation

December 03, 2014

Labels for prescription drugs will more clearly spell out the risks for pregnant and breast-feeding women under final regulations issued today by the US Food and Drug Administration (FDA).

As part of this revamp, labels will no longer use letter categories to describe risk. The current categories are A, B, C, D, and X for pregnant women and A, B, and C for breast-feeding women.

"We determined that the letter category system has become too simplistic and, more importantly, was widely misinterpreted," said Sandra Kweder, MD, deputy director of the Office of New Drugs in the agency's Center for Drug Evaluation and Research, in a news conference today. Drug manufacturers will have to replace the letter categories with "more robust and informative data," said Dr Kweder.

That information is much needed, in light of six million pregnancies each year, she said. Pregnant women take three to five drugs on average for either preexisting conditions or new conditions that arise after conception. Yet the weakness of the current pregnancy and breast-feeding sections of drug labels has forced physicians to look up risk information in other sources, she said.

The new regulations, which have been in the works since 2008, will replace the current sections labeled "pregnancy," "labor and delivery," and "nursing mothers" with "pregnancy," which will include labor and delivery, "lactation," and "females and males of reproductive potential."

The new pregnancy and lactation sections will each contain three subsections: risk summary, clinical considerations, and data. Prescribing physicians will find more detailed information about human and animal studies, adverse events, and dose adjustments needed during pregnancy and the postpartum period. In addition, the pregnancy section must identify any pregnancy exposure registry for the drug.

The section on females and males of reproductive potential will discuss relevant information on pregnancy testing, birth control, and the drug's possible effect on fertility. This information has been in labels all along, but in a scattershot fashion. "It's very difficult to find," said Dr Kweder. "We're pulling it all together in one place."

The new label requirements, which do not apply to over-the-counter drugs, take effect on June 30, 2015. Manufacturers must use the new format immediately for prescription drugs and biologic products approved by the FDA on or after this effective date. For anything approved beforehand, manufacturers will have several years to come into compliance.

The head of the American College of Obstetricians and Gynecologists (ACOG) praised the label changes.

"The FDA's updated method of presenting information about both risk and benefit will improve the ability of all physicians to treat their pregnant and breastfeeding patients, as well as women who may become pregnant," said ACOG President John Jennings, MD, in a news release. ACOG hopes that more detailed labels will spur more research on the effect of prescription drugs on pregnant and breast-feeding women, Dr Jennings added.

More information about the new regulations is available on the FDA website.


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