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No More ABCs: FDA Issues Final Rule on Pregnancy and Lactation Drug Labeling

By: Svetlana Akbasheva, Staff Writer

Pregnancy categories in drug labeling were created in order to facilitate decisions on a medication’s use during pregnancy. With only five possibilities – A, B, C, D, or X – they provided a quick and simple reference regarding a medication’s teratogenic potential. However, in practice this grading system has often caused more confusion than clarity; with many critics arguing that the categories provide an oversimplified view of a very important issue. While categories A, B, and X are pretty clear, what is the correct action for pregnant women who may need a category C or D drug? And how could drugs with widely differing data be placed in the same category?

In response to these criticisms, the FDA decided to implement a more comprehensive format for pregnancy and lactation drug labeling, with the initial proposal being drafted in 2008.1 Six years later, the FDA’s final rule regarding this matter was officially issued on December 3, 2014. The new labeling guidelines discard the pregnancy categories entirely and instead create three mandatory categories for drug monographs – “Pregnancy”, “Lactation,” and “Females and Males of Reproductive Potential.” The “Pregnancy” section will contain a risk summary, clinical considerations, and human and animal data supporting the stated information.2 In addition, it will now be required rather than recommended to include information regarding any existing pregnancy exposure registry for the drug in this section.3 The “Lactation” section will replace the previous “Nursing Mothers” subsection and will also include a risk summary, clinical considerations, and relevant data. Finally, “Females and Males of Reproductive Potential” is a brand new section, which will include information about the need for pregnancy testing or contraception for patients on the medication and whether the drug has any effects on fertility.2

The new labeling guidelines are set to officially go into effect beginning on June 30, 2015. Monographs for new drugs will automatically need to use the new format, while the labeling for existing drugs will gradually adopt the changes. The final rule solely affects prescription drug labeling and has no implications for over-the-counter drugs.3

At a time when many pregnant and lactating women require medications for serious health conditions such as asthma and hypertension, the FDA hopes that these new labeling rules will help physicians and pharmacists make more informed decisions regarding the safe use of medications in this subgroup of patients.



  1. Wood, W. FDA pregnancy categories: help or hindrance? Mental Health Clinician. 2013;3(2):100. http://cpnp.org/resource/mhc/2013/08/fda-pregnancy-categories-help-or-hindrance.
  2. Outline of section 8.1-8.3 on drug labeling. FDA. Updated Dec 03, 2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/. Accessed Jan 07, 2015
  3. Pregnancy and lactation labeling final rule. FDA. Updated Dec 03, 2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm. Accessed Jan 07, 2015

[pubmed_related keyword1=”FDA” keyword2=”pregnancy” keyword3=”lactation”]

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