The U.S. Food and Drug Administration is setting new labeling requirements on prescription drugs and biological products that detail potential risks to pregnant and nursing women. The new requirements, which go into effect June 30, do not apply to over-the-counter medications.
It’s a necessary development. There are more than 6 million pregnancies across the country each year. And, pregnant women take an average of 3 to 5 prescription drugs either for pre-existing or new conditions that arise after conception, according to the FDA.
“The information about the drugs has not changed,” said Dr. Jennifer Ahn, director of OB ultrasound and the Antenatal Testing Center at Akron Children’s Hospital. “But, the new labeling guidelines provide a simplified format in describing risks to the pregnant or nursing mother so it’s not as confusing to read through the info.”
The new standard replaces the current product letter categories, A, B, C, D and X, which were previously used to classify risks of using prescription drugs while pregnant. However, they were inconsistent and confusing to doctors and patients.
For example, there are many drugs in the C category that were tested on animals, but not humans, so it leaves many question marks for the user. Class A and X are more clear-cut, but the ones in-between aren’t as easily understood.
Under the new rule, the FDA requires prescription drug and biologic product manufacturers to include information packets along with the medications that have 3 detailed subsections titled, “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential.” The information will include a more organized risk summary, along with data to support these conclusions.
“The new subsection for reproductive potential is a great addition,” said Dr. Ahn. “This information can help counsel those patients to consider proper use of contraception or to find safer alternative therapies if possible prior to pregnancy.”
In general, it’s best to avoid all drugs while pregnant or nursing, she continued. But for those people that must be on medications, these new guidelines will better guide them.