Pregnancy category

The Pregnancy Category is a classification system used to denote the safety of drugs or other substances during pregnancy. It is a means of assessing the potential risks a drug may pose to the developing fetus. The category system varies from country to country, and it typically ranges from Category A (generally considered safe) to Category X (known to cause birth defects).

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During-pregnancy-pregnancy-by-trimester

U.S. FDA Classification

• The United States Food and Drug Administration (FDA) previously used a letter-based pregnancy category system, but it has since been replaced with a more comprehensive labeling system as of 2015. The old system categorized drugs as follows:
• Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy.
• Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women.
• Category C: Animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans.
• Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.
• Category X: Studies in animals or humans have demonstrated fetal abnormalities, and the risk of use in pregnant women clearly outweighs any possible benefit.

Australia TGA Classification

• The Therapeutic Goods Administration (TGA) in Australia uses a different system:
• Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus.
• Category B: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus.
• Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human fetus or neonate.
• Category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.
• Category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

See Also

• Food and Drug Administration (FDA)
• Therapeutic Goods Administration (TGA)
• Teratogen
• Pregnancy

References

• Briggs GG, Freeman RK, Yaffe SJ (2011). Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk (9th ed.). Lippincott Williams & Wilkins.
• "Pregnancy and Lactation Labeling (Drugs) Final Rule". U.S. Food and Drug Administration (FDA). 2014.
• "Prescribing medicines in pregnancy database". Australian Government – Department of Health – Therapeutic Goods Administration (TGA). 2016.

External Links

Pregnancy Categories - FDA Australian categorisation system for prescribing medicines in pregnancy - TGA Pregnancy category - MedlinePlus

Pregnancy category Resources
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