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Calcitonin (Miacalcic): increased risk of cancer with long-term use – all intra-nasal formulations for osteoporosis to be withdrawn

There is an increased risk of cancer associated with the long-term use of calcitonin. Because of this risk, calcitonin-containing medicines should no longer be used in the treatment of osteoporosis.
All intra-nasal calcitonin sprays, which are the only formulation of calcitonin licensed for osteoporosis, will be withdrawn from the European market.

Calcitonin is a drug used to treat disorders of bone metabolism, such as osteoporosis, Paget’s disease, acute bone loss due to sudden immobilisation and hypercalcaemia of malignancy. Calcitonin, which is not widely used in the UK, is currently available in intra-nasal and injectable formulations.
All available data on the risks and benefits of calcitonin have been reviewed, including data from randomised clinical trials with intra-nasal and unlicensed oral calcitonin formulations. In these trials, 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 review concluded that because of the increased risk of cancer associated with long-term use of calcitonin, the benefits of calcitonin no longer outweigh its risks in the treatment of osteoporosis.

As the intra-nasal spray of calcitonin is only licensed in the indication of osteoporosis the European Committee on Medicinal Products for Human Use (CHMP) has recommended that this formulation should be withdrawn from the European market.

Calcitonin will still be available as a solution for injection and infusion for the short-term treatment of:

  • Paget’s disease – now restricted to patients who do not respond to, or cannot tolerate, alternative treatments (ie, patients with renal impairment). Duration of calcitonin should be limited to up to 3 months, but may be extended to 6 months under exceptional circumstances (eg, patients with impending pathologic fractures)
  • acute bone loss prevention due to sudden immobilisation, for up to 4 weeks only (no change in use)
  • hypercalcaemia of malignancy (no change in use)

In all remaining indications, treatment with calcitonin should be limited to the shortest possible time, using the minimum effective dose.

Advice for healthcare professionals:

  • Healthcare professionals should no longer prescribe calcitonin-containing medicines for the treatment of osteoporosis
  • 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 recommendations
  • While a change in treatment could happen at the next routine appointment, prescribers may wish to see patients sooner

Further information:

Press release from the European Medicines Agency on the withdrawal of intranasal calcitonin

NICE guidance on the treatment of osteoporosis

BNF section 6.6 Drugs affecting bone metabolism

Article citation: Drug Safety Update August 2012, vol 6, issue 1: A1




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