Prolia® (denosumab) - Risk of Unusual Thigh Bone Fractures
MISSISSAUGA, ON, Nov. 21, 2012, 2012 (Canada NewsWire via COMTEX) --
AMGEN Canada Inc., in association
with Heath Canada, would like to inform you of new important safety
information related to the risk of unusual thigh bone fractures
associated with the use of PROLIA.
PROLIA (denosumab) is used to decrease the risk of broken bones in women
who had their menopause and suffer from osteoporosis. It is
specifically prescribed for women at high risk of breaking bones or
those who are unable to take other osteoporosis medicines.
Some people have developed unusual fractures in their thigh bone while
receiving PROLIA. These fractures are called "atypical fractures".
Atypical fractures are very rare. They can occur with minimal or no
impact to the thigh area.
-- Atypical fractures have been reported very rarely, in less than
1 in 10,000 patients treated with PROLIA.
-- Patients with a potential fracture complain of dull, unusual
aching pain in the thigh, hip or groin area.
-- Contact your doctor if you experience new or unusual pain in
your hip, groin, or thigh.
Amgen Canada has worked with Health Canada to update the safety
information for PROLIA and has sent a letter to health care
professionals to inform them of this new important safety information.
A copy of that letter is available on the Health Canada website (www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php). This information is also available at www.amgen.ca.
Managing marketed health product-related side effects depends on health
care professionals and consumers reporting them. Reporting rates
determined on the basis of spontaneously reported post-marketing side
effects are generally presumed to underestimate the risks associated
with health product treatments. Any case of serious atypical fracture
or other serious or unexpected side effects in patients receiving
PROLIA should be reported to Amgen Canada Inc. or Health Canada.
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario L5N 0A4
Safety Tel: 1-866-512-6436 or Fax: 1-888-264-3655
Safety e-mail: firstname.lastname@example.org
You can report any suspected side effect associated with the use of
health products to Health Canada by:
-- Calling toll-free at 1-866-234-2345; or
-- Visiting MedEffect Canada's Web page onAdverse Reaction
for information on how to report online, by mail or by fax
For other health product inquiries related to this communication,
contact Health Canada at:
Marketed Health Products Directorate
SOURCE: Amgen Canada
To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/November2012/21/c2344.html
SOURCE: Amgen Canada
For media inquiries, please contact: Michelle MacLeod Hill+Knowlton Strategies
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