NEW YORK (MainStreet)— Pregnant women and those who are breastfeeding their babies, along with their prescribing doctors, will soon have better information on which to base their medication choices. On December 3, 2014, the U.S. Food and Drug Administration (FDA) published its final rule that sets new standards for how the information about using medicines during pregnancy and breastfeeding is presented in prescription drugs and biological products labeling in order to help clinicians and patients better understand the risks and benefits to the mother, fetus and baby.
Drug manufacturers must now include a risk summary, clinical considerations, and study data.
Currently, prescription drug risk for pregnant and lactating women is based on letter classifications – A, B, C, D and X.
WATCH: More personal finance videos on MainStreet | More videos from Amelia Martyn-Hemphill
“These categories are often not helpful in providing detailed information relevant to making decisions about use in pregnancy and lactation,” said Joanne Stone, M.D., director of maternal fetal medicine at The Mount Sinai Hospital. “Instead, there will be three subsections including pregnancy, which includes labor and delivery medications, lactation, and females and males of reproductive potential.”
“The section on females and males of reproductive potential will provide much needed information [on] prenatal testing, [contraception], and infertility,” Stone continued. “This is a much needed change and will provide patients and health care providers [with] specific and relevant information, including data from drug trials and registries."
According to the FDA, the subsection on pregnancy will include information on dosing, including pregnancy and post-partum dose adjustments; on potential risks to the fetus; and on the existence of a registry that collects data on how the drug or biological product has affected pregnant women. The lactation subsection will include information on the amount of drug that gets in the breast milk and the possible effects on the baby. The subsection on reproductive potential for males and females, which is already included on drug labels but had no consistent placement, will include information about the drug as it pertains to pregnancy testing, contraception, and infertility.
“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations," said Sandra Kweder, M.D, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research in a release. "The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”
Each year in the United States there are more than 6 million pregnancies. Pregnant women take an average of three to five prescription medications.
The final rule will be effective as of June 30, 2015, after which newly approved drug and biological products will be required to use the new format. New labeling for drugs and biological products already on the market will be phased in.
The final rule will apply to drugs approved since 2001.
—Written by S.Z. Berg for MainStreet