Tag: Pregnancy and lactation labeling rule

In 2015, the U.S. Food and Drug Administration (FDA) replaced its letter-based pregnancy safety categories, yet many still question what is a Category C pregnancy safety rating. This former classification indicated that while animal studies may have shown adverse effects, human data was lacking and the potential benefits of the drug could justify the risks.

In 2015, the FDA replaced the pregnancy letter categories, including the often-misinterpreted Category C, with a more detailed narrative rule. This move came because the old system was often seen as overly simplistic and misinterpreted as a grading scale for risk. So, is pregnancy category C bad? The answer is more nuanced than a simple yes or no, relying heavily on context rather than an arbitrary letter.