Pregnancy category

The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.

Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives"

United States

In 1979, the United States Food and Drug Administration (FDA) introduced a classification of fetal risks due to pharmaceuticals. This was based on a similar system that was introduced in Sweden one year earlier. The same guidelines are followed in Pakistan as well.

One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA. See below.

The FDA has proposed updating its approach to labeling. Rather than assigning drugs to categories, there is a narrative description of the evidence available for use of the drug in pregnancy.

This proposal became a final rule on 12/4/2014 and will go into effect on 6/30/2015.

Australia

Australia has a slightly different pregnancy category system from the United States - notably the subdivision of Category B. The system, as outlined below, was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant.

Germany

Categorization of selected agents

The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.

Notes

References

• "Why poison your baby?". Prn2.usm.my. Archived from the original on 2003-05-17. 
• Medicines in Pregnancy Working Party (14 February 2007). "Prescribing medicines in pregnancy". Australian Drug Evaluation Committee. Archived from the original on 2007-06-05. Retrieved 2008-05-21.  â€" links provided for 1999 4th edition and subsequent updates
• Sannerstedt, R.; Lundborg, P.; Danielsson, B. R. et al. (February 1996). "Drugs during pregnancy: an issue of risk classification and information to prescribers". Drug Saf 14 (2): 69â€"77. doi:10.2165/00002018-199614020-00001. PMID 8852521. 
• Food and Drug Administration. Federal Register 1980;44:37434-67
• "Specific requirements on content and format of labeling for human prescription drugs". Labeling Requirements for Prescription Drugs and/or Insulin. Food and Drug Administration. April 1, 1997. Archived from the original on 2008-03-26. Retrieved 2008-05-21. 

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