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.



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