Calcitonin (Miacalcic): increased risk of cancer with long-term use – all intra-nasal formulations for osteoporosis to be withdrawn
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the European Committee on Medicinal Products for Human Use (CHMP) has recommended that this formulation should be withdrawn from the European market.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:
In all remaining indications, treatment with calcitonin should be limited to the shortest possible time, using the minimum effective dose.
BNF section 6.6 Drugs affecting bone metabolism
Article citation: Drug Safety Update August 2012, vol 6, issue 1: A1