FDA pregnancy risk categories and the CPS: do they help or are they a hindrance?
OBJECTIVE
My patient is taking a medication for a chronic condition and has just found out that she is 6 weeks pregnant. The US Food and Drug Administration (FDA) has assigned this medication to pregnancy risk category D, and the Compendium of Pharmaceuticals and Specialties provides no additional data. How should I interpret this information, and how does the Motherisk Program evaluate the safety or risks of drug use in pregnancy?


CONCLUSIONS
Pregnancy safety data provided by the FDA pregnancy risk categories and the Compendium of Pharmaceuticals and Specialties are insufficient to guide clinical decisions on how to proceed with a pregnancy following exposure to a category D medication. The Motherisk Program creates peer-reviewed statements derived from the primary literature, and we examine fetal outcomes as well as the risk-benefit profile of maternal treatment when evaluating the safety of medication use in pregnancy. The FDA announced in May 2008 that it is dropping its pregnancy risk categories and adopting a method similar to the one we use at Motherisk.
Leslie Dan Faculty of Pharmacy, University of Toronto.
Ruth
R
Law
Pina
P
Bozzo
Gideon
G
Koren
Adrienne
A
Einarson
D000014:Abnormalities, Drug-Induced / Q000517:prevention & control; D000328:Adult; D002908:Chronic Disease; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D018811:Maternal Exposure / Q000517:prevention & control; D004364:Pharmaceutical Preparations / Q000145:classification; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects / Q000517:prevention & control*; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations