Calcitonin nasal sprays for osteoporosis to be pulled from market over cancer risk

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OTTAWA - Health Canada says a nasal spray for treating osteoporosis that contains the drug calcitonin will be taken off the market on Oct. 1 due to an increased risk of cancer.

A safety review by the federal department found a slightly elevated risk of cancer linked with prolonged use of calcitonin products.

Calcitonin is used as a nasal spray to treat osteoporosis in postmenopausal women and as an injection to treat the bone disorder Paget's disease and high blood calcium.

Health Canada concluded the cancer risk outweighs the benefit of calcitonin nasal sprays in treating osteoporosis.

Consumers who are using a calcitonin nasal spray should speak to their health-care practitioner about switching to an alternative treatment.

Calcitonin injectable products will continue to be authorized for sale because their benefits are believed to outweigh their risks when used as directed.

However, the injectable products will include a new warning about the cancer risk and patients will be advised to limit their use to the shortest time possible.

There are other authorized medications for the treatment of osteoporosis, Paget's disease and high blood calcium, known as hypercalcemia, Health Canada said.

Consumers are advised to speak to a pharmacist about how to safely dispose calcitonin nasal sprays, which include Miacalcin NS (Novartis), Sandoz Calcitonin NS and Apo-Calcitonin NS (Apotex Inc.).

In March, a U.S. Food and Drug Administration panel of health experts concluded that the bone-strengthening aerosol drug should no longer be used because there is little evidence it works and it might increase the risk of cancer.

That followed a similar recommendation by the European Medicines Agency a year ago after studies showed an increased cancer risk among patients with osteoporosis or osteoarthritis treated with the spray.

Patients given the calcitonin in these trials had higher rates of malignancies compared with patients taking a placebo, ranging from less than one per cent in studies of an oral formulation to 2.4 per cent in studies of a nasal spray.

Organizations: Health Canada, Novartis, Apotex Inc. U.S. Food and Drug Administration European Medicines Agency

Geographic location: OTTAWA

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