On June 30, 2015, the new “Pregnancy and Lactation Labeling Rule (PLLR)” will become effective. This new rule will require content and format changes in the pregnancy and breastfeeding labeling information for prescription drugs and biological products.
The PLLR will replace the current pregnancy letter categories—A, B, C, D and X—which have been criticized for failing to effectively communicate the risk of a drug to a pregnant or nursing women and in females and males of reproductive potential. The U.S. Food and Drug Administration (FDA) expects the new labeling would reduce the confusion and assist healthcare providers in selecting medication based on more detailed risk-benefit information.
How the Pregnancy and Breastfeeding Section Will Change
These are the changes to the drug labeling required by the PLLR:
The Pregnancy and the Labor and Delivery sections in the current labeling will be combined into one: the Pregnancy subsection (8.1). Section 8.1 will include:
• Pregnancy exposure registry information for collecting data regarding the effect of medication on pregnant women
• Risk Summary, which describes the risk of adverse developmental outcomes based on human/animal data
• Clinical Consideration, which will assist healthcare providers with prescribing and counseling
• Data from human/animal research, which supports the information in Risk Summary and Clinical Consideration
The Lactation subsection (8.2) will replace the current Nursing Mothers section, and will include:
• Risk summary regarding the presence of active metabolite transferred to breast milk, the effect of medication on the infant, and the effect of drug on milk production
• Clinical considerations and data
The new section, Females and Males of Reproductive Potential (8.3), will contain information pertaining to pregnancy testing, contraception and infertility.
Concerns About the New Labeling
While addressing the shortcomings of the current prescription drug labeling (i.e., that it is prone to misuse and misinterpretation), the new labeling is not free of concerns: the more detailed information on the labeling will require the prescribers to commit more time to read all the information before being able to prescribe a medication. Some argue that a brief summary should be available as a quick reference.
According to a recent article, “64% of pregnant women use at least 1 prescription drug.” (Feibus KB, 2008) Even without looking at the statistics, there is no doubt that prescribing medication during pregnancy or in patients with reproductive potential requires extra caution. Although the new labeling rule certainly seems more complicated and less intuitive than the old letter categories, many believe that it would be beneficial for healthcare professionals in providing the optimal treatment to the patients through comprehensive assessment of the risk and benefit of a treatment.
- US Food and Drug Administration. Pregnancy and lactation labeling final rule. Updated Dec 4, 2014. Accessed June 2, 2015. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.
- American Pharmacist Association. New pregnancy, lactation drug labeling will replace letter categories. Updated Jan 1, 2015. Accessed June 2, 2015. Available at: http://www.pharmacist.com/new-pregnancy-lactation-drug-labeling-will-replace-letter-categories-0.
- Johnson A. Upcoming changes in pregnancy and lactation product labeling. Inside the Retail Pharmacy. Published May 27, 2015. Accessed June 2, 2015. Vol 3, No 5. Available at: http://www.insidepatientcare.com/issues/2015/may-2015-vol-3-no-5/195-upcoming-changes-in-pregnancy-and-lactation-product-labeling.
- Feibus KB. FDA’s proposed rule for pregnancy and lactation labeling: Improving maternal child health through well-informed medicine use. Journal of Medical Toxicology. Dec 2008, Volume 4, Issue 4, pp 284-288.