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Calcitonin loses osteoporosis indication in Europe due to cancer risk

Nasal sprays be withdrawn while use in other conditions is limited

European regulators have called for calcitonin to lose its osteoporosis indication and for the drug's availability in other conditions to be limited to short-term use due to evidence these medicines can lead to an increased risk of cancer.

“Treatment with calcitonin should be limited to the shortest possible time and using the minimum effective dose,” said the European Medicines Agency (EMA) based on long-term trials that demonstrated the risk of developing cancer was 0.7 per cent to 2.4 per cent higher in patients receiving calcitonin-containing medicines compared to those patients receiving placebo.

The drug, which is a hormone that increases the amount of calcium in the bones and lowers the calcium level in the blood, is used in a variety of bone- and blood-related conditions, including Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer.

However, it will now lose its indication for the treatment of osteoporosis due to the highest risk of cancer being associated with nasal sprays – a method of use that is only associated with the condition that affects bone strength.

“Doctors should no longer prescribe calcitonin-containing medicines as nasal spray for the treatment of osteoporosis,” said the EMA.

For its remaining approved conditions, a maximum treatment period of four weeks is recommended for acute bone loss due to sudden immobilisation and patients with Paget's disease should only be treated with calcitonin if they have not responded to other treatments, with treatment limited to three months.

The review was initiated following preliminary findings from two studies of an unlicensed oral calcitonin medicine, which pointed to a possible association with prostate cancer. These findings, which followed an initial investigation in 2004 from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), were made available to EU national authorities in November 2010.

Following the receipt of the data, the MHRA asked the EMA's Committee for Medicinal Products for Human Use (CHMP) to carry out a full assessment of the benefit-risk balance of calcitonin-containing medicines.

Effected products include Fortical from Upsher-Smith Laboratories) and Miacalcin from Novartis.

23rd July 2012

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