Updated on 23 July 2012
The Committee for Medicinal Products for Human Use has recommended that calcitonin-containing medicines should only be used for short-term treatment
Singapore: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that calcitonin-containing medicines should only be used for short-term treatment, because of evidence that long-term use of these medicines is associated with an increased risk of cancer.
It says doctors should not prescribe calcitonin-containing medicines as nasal spray for the treatment of osteoporosis. Calcitonin will only be available as a solution for injection and infusion, and should only be used for:
• prevention of acute bone loss due to sudden immobilisation, with treatment recommended for two weeks with a maximum duration of four weeks;
• Paget's disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable, with treatment normally limited to three months;
• hypercalcaemia caused by cancer.
Treatment with calcitonin should be limited to the shortest possible time and using the minimum effective dose, says the EMA.
Analysis of all available calcitonin trials showed an increased risk of cancer. In long-term clinical trials the risk of developing cancer was 0.7% to 2.4% higher in patients receiving calcitonin-containing medicines compared to those patients receiving placebo, with the higher rates seen in trials with intranasal calcitonin.
Taking into account the limited efficacy of calcitonin when used to treat post-menopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in this indication. As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation be withdrawn.