The Food and Drug Administration announced new labeling requirements Wednesday meant to better inform doctors and patients about the potential risks of medications taken during pregnancy and breastfeeding.
Under the rule, which has been under consideration since 2008, makers of prescription drugs and other biologic products will soon have to include more detailed and more current information describing how medications might affect pregnant women, mothers and their small children.
The new requirements are intended to revamp a system that experts say is outdated, confusing and generally unhelpful. No longer will labels include letter designations — A, B, C, D and X — that are currently used to classify the risks to patients and have been in use since the 1970s. In their place, the FDA will require information packets that come with medications to have three detailed subsections titled “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential,” which will include a summary of the risks to certain types of patients and data that support those conclusions.
Sandra Kweder, deputy director of the FDA’s Office of New Drugs, told reporters Wednesday that the way the lettering system had been implemented over the years “has been highly, highly inconsistent,” rarely up to date and even misleading. That resulted in a system that left doctors and patients with scant information when considering which drugs to prescribe and which to avoid.
“Our new method provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, the breastfeeding children, and women and men of reproductive age,” Kweder wrote in a blog post after Wednesday’s announcement.
The updated requirements could have a far-reaching effects. There are more than 6 million pregnancies each year in the United States, and on average, pregnant women take three to five prescription drugs during their pregnancy, according to the FDA.
The new rule, which will take effect next June, will apply to all new prescription drugs and biologics, but not to over-the-counter medications. It also will apply to drugs approved since 2001 that have been marketed for years without including updated information related to pregnancy and lactation, the agency said.