Information Update - Calcitonin-containing drugs: Health Canada assessing potential cancer risk with long-term use

OTTAWA, July 31, 2012 /CNW/ - Health Canada is informing Canadians that it is assessing the possibility of an increased risk of cancer with long-term use of the drug calcitonin.

Calcitonin is a prescription drug available in Canada as a nasal spray used to treat osteoporosis (loss of calcium in bones) in postmenopausal women. It is also available as a solution for injection used to treat Paget's disease as well as severe hypercalcemia (high blood calcium). Paget's disease is a chronic condition that causes abnormal bone growth, while severe hypercalcemia is a medical emergency that can lead to, for example, kidney failure, heart problems and coma. A list of calcitonin products in Canada is provided below.

Health Canada is aware of new recommendations from the European Medicines Agency (EMA) to restrict calcitonin use due to evidence suggesting an increased risk of cancer. Specifically, the EMA has recommended that:

• calcitonin nasal sprays should no longer be prescribed for the treatment of osteoporosis
• injectable calcitonin should be used to treat patients with Paget's disease only when other treatments have not worked or are not appropriate, and treatment should normally be limited to three months
• injectable calcitonin should only be used only for hypercalcemia caused by cancer.

Health Canada is currently reviewing all available information to determine appropriate action in Canada. No conclusions or recommendations have been made at this time with respect to calcitonin use in Canada. Health Canada will take the EMA's recommendations into consideration as part of its review. New safety information will be communicated to Canadian prescribers and patients as soon as possible, once the review is complete.

No reports of cancer associated with calcitonin use have been reported to Health Canada since the drug was first authorized in Canada nearly 30 years ago, in 1983.

Patients who are taking a calcitonin medicine who have questions should speak to their health care professional before they consider stopping their calcitonin treatment. There are other medications authorized in Canada for the treatment of osteoporosis, Paget's disease and hypercalcemia.

How to report side effects to health products to Health Canada

To report suspected side effects to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit MedEffect Canada for more information on how to report.

Calcitonin products currently available in Canada

Format	Product Name	Manufacturer	Drug Identification Number (DIN)
Nasal Spray	MIACALCIN NASAL SPRAY 200 IU	Novartis Pharmaceuticals Canada Inc.	02240775
Nasal Spray	APO-CALCITONIN NASAL SPRAY	Apotex Inc.	02247585
Nasal Spray	SANDOZ-CALCITONIN NS	Sandoz Canada Inc.	02261766
Solution for Injection	APO-CALCITONIN INJECTABLE	Apotex Inc.	02246058
Solution for Injection	CALCIMAR SOLUTION INJ 200UNIT/ML	Sanofi-Aventis Canada Inc.	01926691
Solution for Injection	CALTINE INJ 100 UNIT/ML (1ML AMP)	Ferring Inc.	02007134

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SOURCE: Health Canada

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