Pregnancy category

Overview of the pregnancy category system for medications

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Pregnancy category is a classification system used to assess the potential risks of medications to a pregnant woman and her fetus. This system helps healthcare providers and patients make informed decisions about the use of medications during pregnancy.

Overview

The pregnancy category system was originally developed by the United States Food and Drug Administration (FDA) to provide a framework for evaluating the safety of drugs during pregnancy. The categories range from A, B, C, D, to X, with Category A being the safest and Category X indicating that the risks involved in use during pregnancy clearly outweigh potential benefits.

Categories

• Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
• Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
• Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Current Status

In 2015, the FDA replaced the pregnancy category system with the Pregnancy and Lactation Labeling Rule (PLLR), which provides more detailed information about the risks and benefits of drug use during pregnancy and lactation. The PLLR requires drug labels to include a summary of the risks, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions.

See also

• Teratogenicity
• Drug safety during pregnancy
• Pregnancy and Lactation Labeling Rule

External links

• FDA Pregnancy and Lactation Labeling Rule