Calcimar (Synthetic Salmon Calcitonin-Solution for Injection) - Labelling Changes to the Product Monograph Due to an Increased Risk of Cancer with Long-Term Use - For Health Professionals

Starting date:

July 31, 2013

Posting date:

July 31, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product label update, Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-34781

• Related AWRs

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on CALCIMAR (Synthetic Salmon Calcitonin – Solution for Injection)

July 31, 2013

Dear Health Care Professionals,

Subject: Labelling changes to the Calcimar^® (Synthetic Salmon Calcitonin-Solution for injection) Product Monograph due to an increased risk of cancer with long-term calcitonin use.

Sanofi-aventis Canada Inc. (Sanofi Canada), in collaboration with Health Canada, would like to inform you about important changes to the conditions of use for Calcimar^® regarding an increased risk of malignancies (cancer) with long term calcitonin use.

Calcimar^® is indicated in Canada for the early treatment of hypercalcemic emergencies. Calcimar^® is also indicated in the symptomatic treatment of Paget’s disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable.

• Long-term use of calcitonin is associated with a low but observable increased risk of malignancies.
• The treatment with Calcimar^® should be limited to the shortest period of time possible and using the minimum effective dose.
• Calcimar^® use for the symptomatic treatment of Paget’s disease should be restricted to patients who do not respond to alternative treatments or for whom such treatments are not suitable and the duration of treatment should not normally exceed 3 months.

Health Canada has evaluated information on the risk of malignancies from randomised controlled trials in patients with osteoporosis or osteoarthritis receiving calcitonin (salmon) nasal spray or an unlicensed oral calcitonin formulation. Patients treated with calcitonin in these trials had a low, but observable increased rate of malignancies compared with patients taking placebo. The increased rates seen with calcitonin compared to placebo varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.Taking this new safety information into account, Health Canada concluded that the benefits of calcitonin injectable products continue to outweigh the risks when the product is used for short term as directed in the Product Monograph (i.e., for Paget’s disease and hypercalcemia).

Based on this information, the Indications, Warnings, Adverse Reactions as well as the Dosage and Administration sections of the Calcimar^® Product Monograph were updated.

Calcimar^® is still indicated in the early treatment of hypercalcemic emergencies. However, the indication in the symptomatic treatment of Paget’s disease was limited to patients who do not respond to alternative treatments or for whom such treatments are not suitable.

In the symptomatic treatment of Paget’s disease, the treatment should be discontinued once the patient has responded and symptoms have resolved. The duration of treatment should not normally exceed 3 months. Under exceptional circumstances, for example in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months.

The revised Product Monograph for Calcimar^® may be accessed on the Health Canada Web Site, or on the Canadian Website of Sanofi Canada.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of cancer or other serious or unexpected adverse reactions in patients receiving Calcimar^® should be reported to Sanofi Canada or Health Canada.

Sanofi Canada
2905 Place Louis R.-Renaud, Laval
Quebec, Canada
H7V 0A3
Phone: 1-800-265-7927

To correct your mailing address or fax number, contact Sanofi Canada.

You can report any suspected adverse reactions 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 on Adverse Reaction Reporting 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
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 1-613-954-6522
Fax: 1-613-952-7738

Sanofi Canada is fully committed to patient safety and the health and wellbeing of patients taking Calcimar^®. If you have any questions or concerns regarding Calcimar^® or the content of this letter, please do not hesitate to call our Customer Service at 1-800-265-7927.

Sincerely,

original signed by

Franca Mancino
Vice-President, Medical and Regulatory Affairs

Related AWRs

Important Changes to the Availability and Conditions of Use for Drugs Containing Calcitonin

2013-07-31 | Health products

Advisory