Important Changes to the Availability and Conditions of Use for Drugs Containing Calcitonin
- Starting date:
- July 31, 2013
- Posting date:
- July 31, 2013
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
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 health care 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.
NOTE: This document should be read in conjunction with the HPC Nasal Sprays and HPC Injectable which provides additional important safety information for health care professionals regarding these products.