EMA Issues Warning on Osteoporosis Medicines
Posted 23 July 2012 | By
The European Medicines Agency (EMA) announced Friday, 20 June it would recommend against the long-term use of calcitonin-containing medicines, most commonly used to treat or prevent osteoporosis
While the drugs will still be permitted for short-term use for some indications, the agency said there was evidence of an increased risk of cancer when the medications are taken over the long-term. As a result, the medicines should no longer be used to treat osteoporosis, EMA said. The agency also recommended removing nasal spray forms of the product, which it noted are only used for treating osteoporosis and not other, more serious conditions.
Under the new recommendations, physicians should only administer calcitonin medicines through an injection or infusion, and only for acute bone loss, Paget's disease or hypercalcaemia caused by cancer. Paget's disease is characterized by a weakening of the bone structure, causing it to break down or become misshapen, while hypercalcaemia is a condition marked by excess calcium in the bloodstream.
EMA said the more serious risks associated with the three indications outweighed the risks discovered by the agency, which include a 0.7-2.4% increased risk of developing cancer. "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," EMA wrote. All other indications for the drug remain in effect.
EMA's opinion, as drafted by its Committee for Medicinal Products for Human Use (CHMP), now goes to the European Commission for possible adoption.
EMA - European Medicines Agency recommends limiting long-term use of calcitonin medicines