This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Information update

Health Canada reinforces the importance of preventing pregnancy while taking the acne drug isotretinoin to avoid birth defects

Starting date:
September 7, 2016
Type of communication:
Information Update
Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Important Safety Information
General Public
Identification number:

September 7, 2016
For immediate release

OTTAWA - Health Canada is reminding Canadians of the serious risk of birth defects associated with taking the prescription acne drug isotretinoin while pregnant. Health professionals and women who are using, or considering using this drug are reminded of the importance of not getting pregnant while taking this treatment.

Isotretinoin, available under the brand names Accutane, Clarus and Epuris, is used to treat severe acne when other therapies have not worked. It has been available in Canada for more than 30 years.

The reminder comes in light of a recent study commissioned by Health Canada. Health Canada commissioned the study as part of ongoing work to evaluate the risk-management measures currently in place for isotretinoin. The study identified continued reports of pregnancy among patients using isotretinoin, despite the comprehensive risk management measures in place.

There is a known, high risk of birth defects if a woman gets pregnant while taking isotretinoin. This includes malformation of the limbs, head, face, heart and central nervous system of a fetus. To address this risk, Canada, like other countries, has instituted a pregnancy prevention program. Specifically, the program requires patients’ written consent, two negative pregnancy tests before starting treatment, monthly tests during treatment and one month after stopping, and the use of two reliable methods of birth control through this period.

Products are prominently labelled to warn of the risk of birth defects and the importance of actively preventing pregnancy. In addition, manufacturers provide comprehensive patient screening and monitoring tools and advice, reminders to health professionals, educational materials, which both prescribers and patients are strongly encouraged to use, and websites providing pregnancy prevention materials.

Health Canada continues to assess what additional measures may be needed. Canadians will be informed of any new steps to improve the safe use of isotretinoin.

What you should do

  • Know the risks of taking isotretinoin. Even if taken only for a short time, isotretinoin can cause fetal malformations.
  • If you are a female of childbearing age and are planning to use isotretinoin, you and your health care professional should carefully adhere to the pregnancy prevention program. It is essential to use two reliable methods of birth control for at least one month before starting therapy, during therapy, and for at least one month after stopping isotretinoin use. Talk to your doctor about what birth control methods may be right for you.
  • If you do get pregnant while taking isotretinoin, stop taking the drug immediately and consult your health professional.
  • Talk to a health professional about any questions or concerns regarding isotretinoin or effective birth control options.

What industry professionals should do

  • Isotretinoin should be reserved for patients with severe acne who have not responded to conventional first-line acne therapies.
  • Ensure that all patients using isotretinoin (male and female) sign an informed consent form.
  • Ensure that females of childbearing potential fulfill the “Conditions of Use” listed in isotretinoin product monographs.
  • Apply all aspects of the isotretinoin pregnancy prevention program when prescribing isotretinoin. Product monographs provide instructions for obtaining these materials either in hard copy or online.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709