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 (unofficial photo).
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. See Products tab for details.
▲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. See Hazard tab for details.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh
For more information, please contact 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
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 MedEffectTM Canada Web site for information on how to report.
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section.