US-FDA (Food and Drug Administration) Pregnancy Risk Labeling
US-FDA Pregnancy Risk Labeling Rule
In 2015 the FDA replaced the former pregnancy risk letter categories on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers.
Differences between 1979 and the new 2015 rule are detailed below:
1979 FDA Pregnancy Risk Categories (1)
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 from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
2015 (New) US-FDA Pregnancy and Lactation Labeling Rule (PLLR)(2)
The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections and subsections to include:
Pregnancy (includes Labor and Delivery):
Pregnancy Exposure Registry
Risk Summary
Clinical Considerations
Data
Lactation (includes Nursing Mothers)
Risk Summary
Clinical Considerations
Data
Females and Males of Reproductive Potential
Pregnancy Testing
Contraception
Infertility
PLLR Summary
“The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the “Labor and delivery” subsection because information about labor and delivery is included in the “Pregnancy” subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.”(2).
References
United States Food and Drug Administration, CFR - Code of Federal Regulations Title 21, CFR201.80. Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services. Subchapter C - Drugs: General. Part 201 - Labeling. November 29, 2022. Accessed February 17, 2023.
Access Data FDA (Open Access)United States Food and Drug Administration, United States Department of Health and Human Services, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. December 4, 2014. Accessed February 17, 2023.
Federal Register (Open Access)
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