New FDA rule improves labeling of drugs during pregnancy

The U.S. Food and Drug Administration Pregnancy and Lactation Labeling Rule was implemented to address the shortcomings of pregnancy and lactation information in prescription drug labeling.
By Amy Wallace   |   June 15, 2017 at 2:48 PM
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June 15 (UPI) -- The U.S. Food and Drug Administration has implemented its Pregnancy and Lactation Labeling Rule to improve labeling on prescription drugs for pregnant and breast-feeding women.

There are approximately six million pregnancies in the United States each year and more than half of pregnant women report taking at least one medication during pregnancy.

Nearly 81 percent of women breastfeed at some point during their infant's first year, with 52 percent of women still breastfeeding at six months postpartum and 31 percent still breastfeeding at 12 months postpartum.

The FDA determined that the pregnancy letter category system was too simplistic and did not capture the complexities of available risk information and risk-benefit considerations in relation to prescription drug labeling.

The Pregnancy and Lactation Labeling Rule requires drug companies to detail the risks and benefits of prescription drugs or biological products for the mother, fetus, breastfeeding infant and people planning to conceive.

The rule also requires drug manufacturers to update drug and biological product labeling when new information becomes available.

"According to a recent study by the Centers for Disease Control and Prevention on Family Growth in the U.S., approximately 50 percent of women between ages 15 and 44 responded that they intend to have a child in the future," Dr. Mary Cataletto, professor of Clinical Pediatrics at Stony Brook University School of Medicine, said in a press release.

"Healthcare providers responsible for counseling patients who are pregnant, planning to become pregnant, and those who are breastfeeding need a reliable source of information about prescription medications. The new labeling requirement provides a more user-friendly presentation of studies, registries, and available information that can be used to assist providers in discussing medication risks and benefits with their patients."

The study was published in the June edition of Pediatric Allergy, Immunology, and Pulmonology.

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