PROLIA (denosumab) - Association with the Risk of Atypical Femoral Fractures - For the Public

Starting date:

November 16, 2012

Posting date:

November 21, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-15861

This is duplicated text of a letter from Amgen Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Prolia

November 21, 2012

Subject: Prolia^® (denosumab) - Risk of Unusual Thigh Bone Fractures

AMGEN Canada Inc., in association with Health 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 Web site. This information is also available on the Amgen Canada Web site.

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: safetycanada@amgen.com

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect^TM Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Clive Ward-Able, MD

Executive Medical Director

AMGEN Canada Inc.