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FDA pregnancy risk categories and the CPS. Do they help or are they a hindrance?

Ruth Law, Pina Bozzo, Gideon Koren, MD FRCPC FACMT and Adrienne Einarson, RN

March 2010



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?


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.


Une de mes patientes prend des médicaments pour une maladie chronique et vient d’apprendre qu’elle est enceinte de 6 semaines. La Food and Drug Administration (FDA) des États-Unis a classé ce médicament dans la catégorie D de risque durant la grossesse, et le Compendium des produits et spécialités pharmaceutiques ne donne aucune autre information additionnelle. Comment devrais-je interpréter ces renseignements et comment le programme Motherisk évalue-t-il l’innocuité ou le risque des médicaments utilisés durant la grossesse?


Les données sur la sécurité durant la grossesse fournies par les catégories de risque attribuées par la FDA et le Compendium des produits et spécialités pharmaceutiques ne suffisent pas pour guider les décisions cliniques sur la façon de procéder dans le cas d’ une grossesse après une exposition à des médicaments de catégorie D. Le programme Motherisk produit des déclarations révisées par des pairs se fondant sur les ouvrages scientifiques primaires. Nous examinons les résultats chez le foetus ainsi qu’un profil risques-avantages du traitement maternel quand nous évaluons la sécurité de l’usage d’un médicament durant la grossesse. La FDA a annoncé, en mai 2008, qu’elle abandonnait ses catégories de risque durant la grossesse et qu’elle adoptait une méthode semblable à celle que nous utilisons à Motherisk.

The article that appears in the March 2010 issue of Canadian Family Physician correctly identifies the Compendium of Pharmaceuticals and Specialties (CPS) as "the most frequently used reference for evaluating safety when prescribing medication to pregnant women in Canada." The article, written by Ruth Law, et al of Motherisk, may mislead readers about the content of CPS. Indeed "...its [the CPS's] contents are legal product monographs provided by the manufacturers." The product monographs include the FDA pregnancy risk categories because Health Canada requires that information; it is not a requirement of CPS.

The Canadian Pharmacists Association (CPhA) recognized the need for better information regarding the management of pregnant and breastfeeding women many years ago and has taken steps in CPS and our other publications to address this void. In addition to the manufacturer-supplied monographs, the CPS includes 140 nonproprietary monographs compiled by editorial staff at CPhA. These CPhA monographs provide the best available evidence on many widely used drugs and are peer reviewed by Canadian experts. Each CPhA monograph contains a section on pregnancy and breastfeeding. CPhA monographs are indexed and easily identified throughout the CPS.

The Clin-Info section includes a document authored by Motherisk physicians that provides principles of prescribing in pregnancy, and drugs of choice in pregnancy.

CPhA publishes Therapeutic Choices, a peer reviewed Canadian therapeutics reference based on the best available evidence. The sixth print edition—tentatively set for release in spring 2011—will include information on pregnancy and breastfeeding in most chapters. The new section discusses the effects of the condition on pregnancy, the effects of pregnancy on the condition, and includes a discussion of the management of the condition during pregnancy.

Patient Self–Care—another CPhA publication for healthcare professionals addresses treatment of minor ailments and includes an appendix about the treatment of many self–care conditions in pregnancy. This articles is authored by a Motherisk specialist. The second edition of Patient Self–Care is due for release in August, 2010.

CPhA publications are also available to subscribers online at www.e- therapeutics.ca where content is regularly updated. For example, the new pregnancy and lactation information from Therapeutic Choices has already been added to several topics. Other regular updates include revisions to drug monographs, new products and Health Canada advisories.

CPhA provides more than Health Canada-approved product monographs. Our comprehensive print and online resources represent CPhA's commitment to provide the most complete, accessible and relevant drug and therapeutic information for Canadian healthcare professionals. We encourage our readers to look further within CPS,e-CPS and e-Therapeutics when seeking relevant information regarding drug use during pregnancy.

View abstract»»
Can Fam Physician
Vol. 56, No. 3, March 2010, pp.239 - 241
Copyright © 2010 by The College of Family Physicians of Canada

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