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pregnancy category

Safety in pregnancy: A: safety has been established in human studies. no disclosed fetal effects [2] B: presumed safety based on animal studies; animal studies suggest fetal risk [2] C: uncertain safety; animal studies show an adverse effect; no human studies D: unsafe; evidence of risk that may in certain circumstances be justifiable X: highly unsafe; risk of use outweighs any possible benefit +: generally accepted as safe ?: unknown or controversial -: generally regarded as unsafe Notes: - FDA will require drug to be labeled with 3 new sections in lieu of the A,B,C,D,X system [4] - Pregnancy - Lactation - Females and Males of Reproductive Potential - drugs with pregnancy category X should never be given to pregnant or lactating women [3]

Related

medications during pregnancy pregnancy (gestation)

General

pharmacy

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Prescriber's Letter 15(7): 2008 Changes in Store for FDA Pregnancy Category Ratings Detail-Document#: 240710 (subscription needed) http://www.prescribersletter.com
  3. Medical Knowledge Self Assessment Program (MKSAP) 16, 17. American College of Physicians, Philadelphia 2012, 2015
  4. FDA News Release. December 3, 2014 FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm - Pregnancy and Lactation Labeling Final Rule. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm
  5. FDA Pregnancy Categories http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf