New Drug Label Rules For Pregnant Women Coming: FDA

A new labeling system will help provide doctors and expectant mothers with information on the risks and benefits of certain prescription medications to take during pregnancy and while breast-feeding.

"The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breast-feeding child," said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, via Health Day.

New regulations will be available for prescription drugs and biological products beginning on June 30th of next year, according to the U.S. Food and Drug Administration (FDA). 

As it stands, drugs are labeled by a series of lettered categories that are required to classify the risk of medicines during pregnancy and breast-feeding. However, beginning next June, this system will be replaced with three detailed subsections so they will no longer be misinterpreted as a grading system, involving the following three options: "Pregnancy," "Lactation," and "Females and Males of Reproductive Potential."

This is particularly important for doctors who have to make certain decisions based on pregnant women who are dealing with a chronic conditions or for pregnant women who develop a condition during their pregnancy. Furthermore, some medications can increase the risk of infertility.

"For medications that may cause infertility or present risks in pregnancy, the revised labeling will include information to be considered when deciding such issues as birth control or planning a pregnancy," Kweder added.

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