New Medication Labels will Provide More Information for Pregnant, Breastfeeding Women

New Medication Labels will Provide More Information for Pregnant, Breastfeeding Women
December 3, 2014

The U.S. Food and Drug Administration Wednesday finalized new rules that sets labeling standards that outline how medications should be used when a woman is pregnant or breastfeeding.

The new standards will replace the current system with one that includes detailed subsections that provide more information about the medication's risks, benefits, effects on the fetus and infant, and effects on fertility for both men and women.

The current system uses letter categories to classify the risks of using prescription during pregnancy. Public feedback noted that the system was oversimplified and didn't provide enough information about the medication.

"The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child," Sandra Kweder, a deputy director at the FDA, said in a statement.

On average, says the FDA, pregnant woman take three to five prescription drugs to treat existing conditions and new ones that develop during pregnancy. The new labeling standards will provide more information doctors and patients can use to make decisions about their healthcare.

The new labels include three subsections (click here for a formatting example):

Pregnancy: will provide information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus. It will also require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug or product. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now. It will include more information under subheadings for risk summary, clinical considerations and data.

Lactation: will provide information about using the drug while breastfeeding, such as the amount of the drug in breast milk and potential effects on the breastfed child. It will also include the subheadings risk summary, clinical considerations and data.

Females and Males of Reproductive Potential: will include information about pregnancy testing, contraception and about infertility as it relates to the drug. This information has been included in labeling, but there was no consistent placement for it until now.

The new rules goes into effect on June 30, 2015. Newly approved medications will be required to use the new format immediately while existing drugs will be phased in gradually.

To view the new rule, click here.

The draft guidance for industry compliance can be found here after Dec. 4. The public comment period on the draft will be open for 60 days.