New FDA Pregnancy Labeling Standards – Not As Boring As It Sounds!!

Last updated: March 2021

This article explains how the U.S. Food and Drug Administration (FDA) requires medications to be labeled concerning the safety of use during pregnancy and breastfeeding – and if the first half of that sentence makes you want to fall asleep, please bear with me!! I totally understand how the nitty-gritty of medication labeling standards might seem like it would bore you to tears! However, for women living with chronic illnesses like rheumatoid arthritis who may wish to become pregnant or breastfeed their babies, I think these changes actually represent a very exciting development!

Under the old labeling standards, each type of medication was classified into a pregnancy category: A, B, C, D, or X. While these labels may seem like the grades on a report card – grading whether or not a medication is safe for use during pregnancy – that was not the case. Instead, these labels merely showed the amount of data available for risk assessment. For example, pregnancy category A indicated that there were adequate and well-controlled human studies on that particular medication and that those studies had failed to demonstrate a risk to a fetus. Pregnancy category B indicated that animal reproduction studies had failed to demonstrate a risk to the fetus, but that there were no adequate and well-controlled studies in humans (or, alternatively, that animal studies did show an adverse effect but that adequate studies in humans failed to demonstrate the same risk).

If you’re confused by the previous two sentences that’s ok – it’s confusing! Though the single letter labels were meant to indicate the amount of data available to evaluate risk in a simplified manner, in reality they turned out to be rather confusing and were often misinterpreted by patients as a safety grading system. On top of being confusing, the old system was actually a bit misleading when it came to evaluating the true overall risk involved in taking a particular medication while pregnant – because it failed to give any consideration to the risks associated with untreated maternal disease (i.e. if the mother’s disease is active while she is pregnant, that can create risks for the baby too.)

So, about two years ago on December 3, 2014, the FDA issued a final rule setting new standards for labeling medications to indicate the risk of their use during pregnancy and breastfeeding. This new rule took effect as of June 30, 2015. All newly approved medications will be required to use the new format immediately, while previously approved products will adopt the new labeling requirements gradually over the next three to five years.

The new system completely revamps pregnancy and breastfeeding risk labeling. Instead of a single letter, each medication will now have a more integrated risk summary with the goal of providing doctors and moms-to-be with more complete information with which to evaluate risk. The new labels will provide explanations, still based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child – but will do so within the real-world context of caring for pregnant women who may need medications to control their own diseases.

The new system does lose the succinctness of the single letter labeling system, which means that it may be a bit more difficult for patients to digest all the information about the potential risks. Patients may need to really push their doctors to take the time to properly explain and evaluate all the pros and cons before coming to a decision concerning medication use while pregnant or breastfeeding. Still, I think having more robust information is a really great thing! The new labeling system will allow a woman and her doctor to more realistically evaluate the risk, on both sides, of stopping or staying on a medication while pregnant or breastfeeding. I think this may potentially allow more women with chronic illnesses to pursue dreams of motherhood and breastfeeding – and suffer less while doing so.

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

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