Calcitonin intra-nasal formulations withdrawn due to cancer risk

Intra-nasal formulations of calcitonin are being withdrawn after long-term use of the osteoporosis drug was linked to a raised risk of cancer

The MHRA has warned that there is an increased risk of cancer associated with the long-term use of calcitonin. The agency said that, because of this risk, calcitonin-containing medicines should no longer be used in the treatment of osteoporosis.

Calcitonin is currently only licensed for use in osteoporosis as an intra-nasal spray and all intra-nasal formulations will be withdrawn from the European market. It is marketed as Miacalcic Nasal Spray.

Calcitonin is not widely used in the UK, but it is currently available in intra-nasal and injectable formulations. It is used to treat disorders of bone metabolism, such as osteoporosis, Paget’s disease, acute bone loss due to sudden immobilisation and hypercalcaemia related to malignancy.

Calcitonin will remain available as a solution for injection and infusion for the short-term treatment of Paget’s disease, hypercalcaemia of malignancy and acute bone loss prevention due to sudden immobilisation. In all remaining indications, treatment with calcitonin should be limited to the shortest possible time, using the minimum effective dose.

The MHRA said available data suggested that different types of malignancies were observed more frequently in patients treated with calcitonin, compared with placebo. The absolute increased risk of cancer varied between 0.7% and 2.4%.

The agency said that patients who are currently being treated with intra-nasal calcitonin for osteoporosis should be reviewed and changed to another suitable treatment in line with NICE advice. It added that a change in treatment could happen at the next routine appointment, but that prescribers may wish to see patients sooner.

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