Skip to main content

Main menu

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Instagram
  • Listen to CMAJ podcasts
Letters

A preventable teratology: isotretinoin

R. Douglas Wilson
CMAJ September 06, 2016 188 (12) 901; DOI: https://doi.org/10.1503/cmaj.1150114
R. Douglas Wilson
Cumming School of Medicine, University of Calgary, Calgary, Alta.
MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

It was concerning to read Henry and colleagues’ study on the poor adherence to pregnancy prevention while women are taking isotretinoin.1

This drug was first licensed in 1982 in the United States, and the first reports on concerns about birth defects occurred within a year. Recommendations from the Teratology Society were first published in 1991.2

The reported risk for isotretinoin embryopathy is 35% for an embryo or fetus that is exposed beyond the 15th day after conception.3 The evidence supports the exposure to the embryo or fetus as the risk, not the use of the medication before conception. The embryopathy is well described, with craniofacial, cardiovascular and central nervous system (CNS) “disruptive” anomaly patterns.

Subnormal intelligence was also reported in a prospectively collected cohort of 31 five-year-old children exposed prenatally, with 19% having a full-scale intelligence quotient (IQ) less than 70 and 28% having an IQ in the 71–85 range.4 The intellectual deficit was not always associated with the finding of other non-CNS major disruptive anomalies: 6 of 10 children with borderline IQ had no identified major anomalies (all the children with severe IQ deficit had other identified major anomalies).

This evidence point is important for the clinical use of ultrasound screening of the exposed embryo or fetus for congenital anomalies and having the conclusion of “no anomalies, therefore not affected.”

Henry and colleagues’ results indicate that a much stronger warning and more counselling are likely required to prevent pregnancy. The teratology messaging needs to start first with the prescribing physician and informed consent from the patient. However, there needs to be stronger oversight from industry and the dispensing pharmacist (who should ask, “What birth control method will you be using while you are taking this medication?”).

Improved knowledge translation about teratology and changes to the prescribing process clearly fit into the Choosing Wisely theme. This type of exposure to the embryo or fetus is entirely preventable. Isotretinoin embryopathy is not an acceptable pregnancy outcome, even when one considers patients’ autonomy and their choice of method for preventing pregnancy.

References

  1. ↵
    1. Henry D,
    2. Dormuth C,
    3. Winquist B,
    4. et al
    . Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ 2016;188:723–30.
    OpenUrlAbstract/FREE Full Text
  2. ↵
    Recommendations for isotretinoin use in women of childbearing potential. Teratology 1991;44:1–6.
    OpenUrlCrossRefPubMed
  3. ↵
    Retinoic acid embryopathy. In: Jones KL, Jones MC, del Campo M. Smith’s recognizable patterns of human malformation, 7th ed. Philadelphia: Elsevier; 2013:742–3.
  4. ↵
    1. Lammer EJ,
    2. Hayes AM,
    3. Schunior A,
    4. et al
    . Risk for major malformations among human fetuses exposed to isoretinoin (13-cis-retinoic acid). Teratology 1987;35:68.
    OpenUrl
PreviousNext
Back to top

In this issue

Canadian Medical Association Journal: 188 (12)
CMAJ
Vol. 188, Issue 12
6 Sep 2016
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
A preventable teratology: isotretinoin
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
A preventable teratology: isotretinoin
R. Douglas Wilson
CMAJ Sep 2016, 188 (12) 901; DOI: 10.1503/cmaj.1150114

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
A preventable teratology: isotretinoin
R. Douglas Wilson
CMAJ Sep 2016, 188 (12) 901; DOI: 10.1503/cmaj.1150114
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
    • References
  • Responses
  • Metrics
  • PDF

Related Articles

  • Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • The 5 Ps need an update: toward a comprehensive sexual history
  • Don’t ignore perimenopause
  • Hospital-at-home programs in Canada: challenges and pitfalls
Show more Letters

Similar Articles

 

View Latest Classified Ads

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • CPD credits
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Advisory Panels
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions
CMAJ Group

Copyright 2023, CMA Impact Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

To receive any of these resources in an accessible format, please contact us at CMAJ Group, 500-1410 Blair Towers Place, Ottawa ON, K1J 9B9; p: 1-888-855-2555; e: [email protected]

CMA Civility, Accessibility, Privacy

 

Powered by HighWire