Osteoporosis Drug Removed from the Market

Health Canada released information on Calcitonin (Salmon) Nasal Spray's market withdrawal several weeks ago.   In addition to Canada's move the European Medicines Agency (EMA) also removed this drug as well due to increases in cancer risk.

Calcitonin is an agent that increases calcium in the bone and lowers calcium levels in the blood, which is used for both osteoporosis and Paget's disease.   This information was a result of two studies conducted on the possible release of an oral form of Calcitonin when the increased cancer risk was found.

Evidence surfaced that prolonged use of Calcitonin is associated with increased cancer risk and therefore the risk benefit reward has changed.   Although the cancer rates reported in the studies were low, the increase in cancer rates seen with calcitonin varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation. Taking into account the increased rate of cancer with long-term use and the limited benefit of calcitonin when used to treat post-menopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition. As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used (European Medicines Agency, 2013).

Health Canada will not remove the drug until October 1st 2013.   The European Medicines Agency along with Health Canada will still sell the injectable form of Calcitonin for Paget's, hypercalcemia and for prolonged immobilization to prevent bone loss, but only for a short period of time.

Since the drug will remain on the market till October, this will give health care professionals time to prescribe an alternate medication.

For more information, speak to your health care provider, or contact the Canadian drug manufacturers below.

MIACALCIN ® NS:ovartis Pharmaceuticals Canada Inc.
385 Bouchard blvd,
Dorval, Quebec, H9S 1A9
Phone: 1-800-363-8883 (Medical Information)
Fax:514-636-3175

SANDOZ CALCITONIN NS: andoz Canada Inc.****
145, Jules-Leger,
Boucherville, Quebec, J4B 7K8
Phone: 1-800-361-3062 (Drug Information)

APO-CALCITONIN NS: potex Inc.,****
150 Signet Drive,
Toronto, Ontario M9L 1T9
Phone: 1-800-667-4708 (Drug Safety)
Fax: 1-416-401-3819
Email: drugsafety@apotex.com

Source:

European Medicines Agency.   European Medicines Agency recommends limiting long-term use of calcitonin medicines. 20 July 2012. Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/07/WC500130122.pdf

Healthy Canadians. Synthetic Calcitonin (Salmon) Nasal Spray (NS) - Market Withdrawal of All Products, Effective October 1st, 2013 - For Health Professionals.   July 31, 2013 Retrieved from:   http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34783a-eng.php