Health Canada

Health Canada

July 09, 2009 13:32 ET

Health Canada Update About Safety of Lantus (Insulin Glargine)

OTTAWA, ONTARIO--(Marketwire - July 9, 2009) - Health Canada is informing Canadians of an ongoing safety review of the potential association between the diabetes drug Lantus (insulin glargine) and an increased risk of developing cancer.

A similar review was recently announced by the U.S. Food and Drug Administration and the European Medicines Agency in light of four recently published studies that looked at the use of Lantus and the development of various types of cancer in patients with diabetes.

Three of the four studies suggested a very slightly increased risk of cancer associated with use of Lantus, while the fourth study found no link between the drug and the development of cancer. In all studies, the number of patients who developed cancer was small. The four studies were published in Diabetologia (http://www.diabetologia-journal.org/cancer.html).

Lantus is a long-acting synthetic insulin similar to human insulin that is used to control blood sugar in people with type 1 and type 2 diabetes. It has been marketed in Canada since February 2005 by the company Sanofi-Aventis.

At this time, Health Canada recommends that patients should not stop taking their insulin therapy without first consulting their physician, as uncontrolled blood sugar can have both immediate and long term serious health consequences. Patients should contact their health care professional if they have any concerns about the medicines they are taking.

Health Canada has not concluded that there is a relationship between Lantus and the development of cancer. The Department is currently assessing available safety data, including the studies, to better understand the risk, if any. Health Canada will inform Canadians and health care professionals of new safety information as it emerges, as appropriate.

You can report any adverse reactions associated with the use of Lantus to the Canada Vigilance Program by one of the following three ways:

- Report online (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada section of the Health Canada Web site

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and either:



- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9


To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada section of the Health Canada Web site. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this section.

Egalement disponible en francais

Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709