Silver Spring, MD—If pharmacists are sometimes unsure when questioned about the safety of a drug for pregnant or breastfeeding women, the new FDA Pregnancy and Lactation Labeling Rule should help.
A study published in Pediatric Allergy, Immunology, and Pulmonology points out that the new labeling format offers a summary of the evidence-based risks. That’s in contrast to the previous labeling, which was easy to misinterpret, according to the review.
In the article, authors FDA describe the new labeling rule, how it is being implemented, and how it improves on the existing labeling system. The new labeling requirements specify the risks of a prescription drug or biological product for the mother, fetus, and breastfeeding infant, as well as for women and men of reproductive age and potential.
Background information in the article states that 6 million pregnancies occur in the U.S. every year, and more than 50% of pregnant women report taking at least one medication. In terms of lactation, 81% of women will breastfeed at some point during their infant’s first year of life, with 52% of women still breastfeeding at 6 months postpartum and 31% of women still breastfeeding at 12 months postpartum.
The Pregnancy and Lactation Labeling Rule (PLLR) was issued on June 30, 2015, after the agency determined that the previous pregnancy letter category system was overly simplistic because it did not capture the complexities of available risk information and risk-benefit considerations.
“In addition, the pregnancy letter categories were misinterpreted as a grading system that resulted in prescribing decisions that were based on incorrect assumptions for the known risks of the drug,” the report notes. “The new labeling format under PLLR is structured to better help providers communicate important information about the risks and benefits of taking a specific medication to their pregnant or breastfeeding patients.”
The PLLR requires drugs and biological products approved after June 30, 2001, to update the information found in the Pregnancy and Nursing Mothers sections of the label and to remove the letter category by June 2020.
For drugs approved before June 30, 2001, pregnancy letter categories A, B, C, D, and X are required to be removed from all prescription drug and biological product labeling, including generic labeling, by June 30, 2018, according to the report.
Instead of the old format, the new labels should include integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. Perhaps most helpful for pharmacists, the new format requires a discussion of data supporting the Risk Summary and relevant information to help healthcare providers counsel women about the use of drugs during pregnancy and lactation.
« Click here to return to Weekly News Update.