An overview of upcoming changes in pregnancy and lactation labeling information

  • Juan F. Mosley II
  • Lillian L. Smith
  • Megan D. Dezan
Keywords: Drug Labeling, Pregnancy, Lactation, United States Food and Drug Administration, United States

Abstract

Background: Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult.

Discussion: In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system.

Conclusion: The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice.

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References

1. Department of Health and Human Services. Food and Drug Administration. 21 CFR Part 201. Content and Format of Labeling Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. Published 12/04/2014. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf (accessed March 20, 2015).

2. Centers for Disease Control and Prevention. Treating for Two: Data and Statistics. Updated: February 19, 2014. Available at: http://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html (accessed March 20, 2015).

3. Ramoz LL, Patel-Shori NM. Recent Changes in Pregnancy and Lactation Labeling: Retirement of Risk Categories. Pharmacotherapy. 2014;34(4):389-395. doi: 10.1002/phar.1385

4. Food and Drug Administration. Kefauver-Harris Amendments Revolutionized Drug Development. Published October 2012. Available at: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM322886.pdf (accessed March 20, 2015).

5. Aschenbrenner DS. Drug Watch: The FDA Proposes Revisions to Pregnancy Information in Drug Labeling. Am J Nurs. 2008;108 (11):32-34.

6. U.S. Food and Drug Administration. Promoting your health. Pregnancy and Lactation Labeling Final Rule. Published 12/3/2014. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm (accessed: March 20, 2015).
Published
2015-06-18
Section
Review

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