Health Canada Update About Safety of Lantus (Insulin Glargine)

OTTAWA, ONTARIO, Jul 09 (MARKET WIRE) --
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(TM) 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-en
.php)
from the MedEffect(TM) 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

Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709

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