FDA rule requires drug labels detail risks to pregnant women

Pharmaceutical companies are facing new labeling requirements on drugs that could pose a risk to pregnant women. 

The Food and Drug Administration (FDA) announced Wednesday it is overhauling the pregnancy labeling requirements on prescriptions drugs and biological products.

ADVERTISEMENT

"More information about drugs will be provided than ever before," said Sandra Kweder, the FDA's deputy director of the office of new drugs.

Companies will be required to provide relevant information to doctors about the risks their drugs pose to pregnant women, women who are breastfeeding, and their children.

The FDA is concerned doctors don’t have enough information about how prescription drugs affect pregnant women. The new requirements will make companies summarize any available information on their labels.

"Often times, companies know about the information in the medical literature and they have chosen for whatever reason not to use it," Kweder said.

Currently, the pregnancy information provided on prescription drugs, if any, can be "very difficult for physicians to make sense of," she added. "Clinicians don't understand it.”

The FDA proposed the rules in 2008, and is just now finalizing them. The rules will go into effect on June 30, 2015.