Major changes in prescription drug labels are being proposed by the FDA concerning how to inform doctors about drug risks during pregnancy and breastfeeding.

FDA’s nearly 30-year-old pregnancy category system for prescription drugs is being revised to help doctors prescribe drugs and counsel women who are pregnant, lactating, or of childbearing age.

FDA commissioner Andrew Von Eschenbach told reporters in a news conference, “As a physician, a husband, a father, and even a grandfather, I'm well aware that the most important question a woman asks when taking a drug when she finds out that she’s pregnant is the question, ‘Will this hurt my baby?’

FDA wants to provide the right information and in the right way to appropriately address that question, Eschenbach said.

Statistics show that America has about 6 million pregnancies per year with pregnant women taking an average of 3 to 5 prescription drugs including drugs to treat chronic and pregnancy-related conditions.

According to the FDA, they began grouping prescription drugs in 1979 with five pregnancy categories to describe drugs’ risks when used during pregnancy: A, B, C, D, and X.

Rear Admiral Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research said that the system, which hasn’t changed since it was established, “has led to an inaccurate and overly simplified view of prescribing in pregnancy and the attendant risks.”

According to Kweder, the pregnancy category system has also “by its very nature, made it very difficult to update labeling as new information becomes available.”

The FDA proposal will eliminate the system and will summarize what’s known about drugs’ risks during pregnancy and lactation. The pregnancy section of drugs’ physician labeling would include three subsections:

• Fetal Risk Summary: What’s known about the effects on the fetus
• Clinical Considerations, such as dosing, risks of not treating conditions, and complications
• Data: More details on the data used to write the fetal risk summary and clinical considerations

The FDA proposal also requires labels to address the risk that any developing baby has of being born with a birth defect, regardless of drug use, to put the drug information in context.

However, the proposed label changes don’t end with pregnancy. It will also address drug use during breastfeeding that would cover topics whether the drug can be found in human breast milk, what effect that might have on a breastfed baby, and how those risks compare to breastfeeding’s known benefits.

When the FDA proposal gets finalized, all new drugs would use the new pregnancy labeling format, and previously approved drugs would transition to the new format.