Other safety alerts
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| Canada: Health Canada reinforces the importance of preventing pregnancy while taking the acne drug isotretinoin to avoid birth defects |
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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 in Canada, 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.
Patients are advised that if they are a female of childbearing age and are planning to use isotretinoin, they and their 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. If they do get pregnant while taking isotretinoin, stop taking the drug immediately and consult their health professional.
Healthcare professionals are advised of the following:
• 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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../60096a-eng.php
In Hong Kong, there are 12 registered pharmaceutical products containing isotretinoin, and are prescription only medicines. It is required that a patient information leaflet, in both Chinese and English, should be provided in each package of the product containing isotretinoin, highlighting the teratogenic effect of the product. So far, the Department of Health (DH) has received one adverse drug reaction case in connection with isotretinoin, and it was related to miscarriage. As Health Canada is continuing to assess what additional measures may be needed to improve the safe use of isotretinoin, DH will remain vigilant on the conclusion of the review and any safety update on isotretinoin by other overseas drug regulatory authorities.
Ends/ Thursday, September 08, 2016
Issued at HKT 15:00
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