Calcitonin Linked to Cancer Risk, EMA Warns

Disclosures

July 20, 2012

July 20, 2012 — The European equivalent of the US Food and Drug Administration (FDA) yesterday recommended withdrawing calcitonin nasal spray — indicated for treating osteoporosis in the European Union — because of an increased risk for cancer.

The European Medicines Agency (EMA) also said that the long-term use of calcitonin-containing medicines delivered by injection or infusion increases the risk for cancer. As a consequence, the EMA recommended that these 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.

Calcitonin in any formulation should not be used to treat osteoporosis at all, the agency said.

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 EMA said it based its recommendations on a review of the benefits and risks of calcitonin-containing medicines. Conducted by the agency's Committee for Medicinal Products for Human Use (CHMP), the review encompassed available data from the companies that market these drugs, postmarketing safety data, randomized controlled studies, 2 studies of unlicensed oral calcitonin drugs, and experimental cancer studies, among other sources.

CHMP found that "a higher proportion of patients treated with calcitonin for long periods of time develop cancer of various types, compared with patients taking placebo." The increase in cancer rates ranged from 0.7% for oral formulations to 2.4% for the nasal formulation. CHMP concluded that the benefits of calcitonin for osteoporosis did not exceed the risks. The nasal spray's only indication is for osteoporosis, thus justifying the drug's removal from the market.

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. The agency did not specify a time frame for the short-term use of calcitonin for treating hypercalcemia caused by cancer.

The EMA recommendations about calcitonin go next to the European Commission, the executive branch of the European Union, for its decision. More information about the EMA's recommendation is available on the agency's Web site.

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