ADR that result in revision of patient information
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| Canada: Important changes to the availability and conditions of use for drugs containing Calcitonin |
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Health Canada is informing Canadians of important changes to the availability and recommended conditions of use of drugs containing calcitonin. Calcitonin is used as a nasal spray to treat osteoporosis (loss of calcium in bones) in postmenopausal women and as an injection to treat Paget's disease (a chronic bone disorder) and hypercalcemia (high blood calcium).
A safety review conducted by Health Canada has concluded that there is a slightly increased risk of cancer associated with the prolonged use of calcitonin products. A review of the benefits and risks of the nasal spray products found that there was not enough evidence of benefit to continue using calcitonin nasal sprays in treating osteoporosis, given the increased risk of cancer. As a result of these reviews, calcitonin nasal spray products will no longer be authorized for sale in Canada as of October 1, 2013. This transition period will allow patients using calcitonin nasal spray to be transferred to other treatments.
Calcitonin injectable products will continue to be authorized for sale in Canada. The benefits of these products are considered to outweigh the risks when the product is used as directed in the Product Monograph (i.e., for Paget's disease and hypercalcemia). However, the labels for calcitonin injectable products are being updated to include a new warning about this risk, and to recommend that treatment with calcitonin solution for injection be limited to the shortest possible time, using the minimum effective dose. Treatment of symptomatic Paget's disease with calcitonin medicine should be limited to patients who are unable to use other treatments. Patients who are taking a calcitonin medicine and who have questions should speak to their healthcare practitioner before making any change to their treatment. There are other medications authorized in Canada for the treatment of osteoporosis, Paget's disease and hypercalcemia. Patients should speak to their pharmacist regarding the safe disposal of calcitonin nasal spray products.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../34843a-eng.php
In Hong Kong, there are 4 registered pharmaceutical products containing calcitonin and are prescription-only medicines. Miacalcic Nasal Spray 200iu (HK-43614) and Apo-Calcitonin Nasal Spray 200iu/spray (HK-58746) are nasal sprays, while Miacalcic Inj 100iu/ml (HK-27880) and Miacalcic Inj 50iu/ml (HK-28413) are injectable products. The nasal spray products are indicated for neurodystrophic disorders, bone pain associated with osteolysis or osteopenia and Paget's disease of bone, whereas injectable products have additional indications for hypercalcemia and as adjuvant therapy for acute pancreatitis. All the four products are NOT indicated for the treatment of osteoporosis. The package inserts highlight that the treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose. Related news had been released by various authorities and were posted on the website of Drug Office. Letters to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug were issued on 23 July 2012 and 3 April 2013. The matter was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board in April 2013. The Committee decided that calcitonin should no longer be used for the treatment of osteoporosis and the sales pack labels and/or package inserts should include the new warning of treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose. The Department of Health will keep vigilant on any safety updates of the drug.
Ends/ Thursday, August 01, 2013
Issued at HKT 12:30
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