European Medicines Agency bans Calcitonin use for treatment of Osteoporosis

The European equivalent of the US Food and Drug Administration (FDA) yesterday(20-7-2012) recommended withdrawing calcitonin nasal spray — indicated for treating osteoporosis in the European Union — because of an increased risk for cancer(Ca Prostate)
The European Medicines Agency (EMA) recommended that this drugs be used only on a short-term basis for 3 conditions for which they had previously been approved in the European Union: Paget’s disease, acute bone loss resulting from sudden immobilization, and hypercalcemia caused by cancer.
The EMA strongly recommended against use of calcitonin for the treatment of osteoporosis
In the United States, 2 nasal-spray versions of calcitonin are FDA-approved for treating postmenopausal osteoporosis in women: Fortical (Upsher-Smith Laboratories) and Miacalcin (Novartis). Neither of the labels for the 2 drugs contains restrictions on how they should be used or a warning about the risk for cancer.
Calcitonin, also called calcitonin-salmon, is a synthetic copy of a polypeptide hormone secreted by the ultimobranchial gland of salmon.
The data has been analysed based on randomized controlled studies, 2 studies of unlicensed oral calcitonin drugs, and experimental cancer studies, among other sources.
Although based on small numbers, cancer mortality was also higher in patients treated with calcitonin in these trials, which may indicate a treatment dependent increased risk of tumour promotion
Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations
The increase in cancer rates ranged from 0.7% for oral formulations to 2.4% for the nasal formulation.
As a solution for injection or infusion, calcitonin should be administered for no more than 4 weeks to prevent acute bone loss resulting from sudden immobilization, and normally for no more than 3 months to treat Paget’s disease, the EMA said.