Over the years, many women have reached out, often distressed, about discovering they were pregnant while taking medications classified as Category X or D by the FDA. “I’ve been on birth control and still got pregnant! Does this mean my baby will have defects? It’s a category X drug!” Such panicked calls were all too common, leading some to even consider ending pregnancies they truly wanted. Recognizing the confusion these categories caused, the FDA phased out this system in 2014, replacing it with the Pregnancy and Lactation Labeling Rule (PLLR), which offers clearer, narrative summaries about medications, much like what you can find on our blog.
A Bit of History
For decades, the FDA was aware of the inefficiencies in how medications were categorized for pregnancy use. In 1992, the Teratology Society (now the Society for Birth Defects Research and Prevention) raised concerns that the Category system led to unnecessary terminations of wanted pregnancies. The FDA’s initiative aimed to eliminate the CAT system, replacing it with more detailed risk statements and the requirement for drug inserts to be updated when new human data became available.
Previously, medications were assigned one of five pregnancy categories: A, B, C, D, or X. Category A indicated a drug had been well-studied and posed no risk; B suggested it was less studied but likely low-risk; C meant the risk was unknown due to lack of studies; D indicated potential risks based on prior data; and X classified drugs as harmful enough to recommend against their use in pregnancy.
Shockingly, over 90% of new drugs fell into categories C, D, or X, with most being C. While manufacturers had to update categories if harmful effects were identified, there was no obligation to do so if studies showed no risks. As a result, many medications in 2014 were misclassified, which likely stemmed from manufacturers wanting to hedge against potential lawsuits. Why risk moving a medication from C, D, or X to A or B when they could avoid liability?
What This Means for Expecting Mothers
With the FDA’s 2014 rule change, new requirements were introduced to better inform expectant mothers. Manufacturers must now update medication labels when new studies indicate a change in risk. They’re also encouraged to provide detailed discussions about risks, which could involve consulting with teratogen information services, like those we offer.
A Note on Ongoing Confusion
As the new labeling system rolls out, many drugs will still display the old CAT system until they can be updated. It’s essential not to rely on the outdated CAT classifications for risk assessment. If you have questions about medication safety during pregnancy, we’re here to help you with personalized assessments.
For more information on specific medications, you might also find our post on oxybenzone helpful. And if you’re exploring home insemination options, the insights from Make A Mom on their at-home insemination kit are worth checking out. For a comprehensive overview of pregnancy-related topics, Healthline is an excellent resource.
Summary
The FDA’s transition away from the outdated pregnancy risk categories aims to provide clearer guidance for expectant mothers regarding medication use during pregnancy. This change seeks to reduce confusion and improve safety, allowing women to make informed decisions about their health.