Intranasal calcitonin withdrawn owing to cancer risk

Miacalcic Nasal Spray (calcitonin) is being withdrawn owing to an increased risk of cancer with long-term calcitonin use.

Calcitonin is no longer licensed for use in osteoporosis, and will only be available as a solution for injection and infusion.  | SCIENCE PHOTO LIBRARY
Calcitonin is no longer licensed for use in osteoporosis, and will only be available as a solution for injection and infusion. | SCIENCE PHOTO LIBRARY

A review of all available data (including two studies of an unlicensed oral calcitonin preparation, post-marketing safety data and randomised controlled studies) showed that patients treated with calcitonin for long periods of time were more likely to develop malignancies than those taking placebo. The increase in cancer risk varied from 0.7% for the oral formulation to 2.4% for the nasal formulation, the only preparation licensed for long-term use – to reduce the risk of vertebral fractures in postmenopausal osteoporosis.

Risk–benefit analysis

Taking into account the limited efficacy of calcitonin in osteoporosis, the EMA concluded that the benefits of calcitonin did not outweigh the risks in this setting. Patients currently being treated with intranasal calcitonin should be reviewed and switched to an alternative osteoporosis treatment in line with NICE recommendations.

Calcitonin injection

Injectable calcitonin (Miacalcic Injection) remains available for short-term use in the prevention of acute bone loss due to sudden immobilisation, and for the treatment of Paget’s disease and hypercalcaemia of malignancy. Use in Paget’s disease is now restricted to patients who do not respond to, or cannot tolerate, other treatments.

MHRA Drug Safety Update August 2012

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