Yesterday the EMA, the European equivalent of the US FDA, recommended withdrawing calcitonin nasal spray – indicated for treating osteoporosis in the European Union, because of an increased risk for cancer.
The EMA also said that long-term use of calcitonin-containing medicines delivered by injection or infusion can increase the risk of cancer. Consequently, the agency recommended that these drugs be used only on a short-term basis for the three conditions for which they had previously been approved in the EU, namely 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.
In the United States, two nasal-spray versions of calcitonin are FDA-approved for treating postmenopausal osteoporosis in women, and neither of the labels for the drugs contain restrictions on how they should be used or a warning about the risk of cancer.
Calcitonin, also known as calcitonin-salmon, is a synthetic copy of a polypeptide hormone secreted by the ultimobranchial gland of salmon.
The EMA 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 the market these drugs, postmarketing safety data, randomized controlled studies, two studies of unlicensed oral calcitionin drugs, and experimental cancer studies, among other sources.
It was found by the CHMP that a higher proportion of patients treated with calcitonin for long periods of time develop cancer of various times, compared with patients taking placebo. The increase in cancer rates ranged from 0.7% for oral formulations, 2.4% for nasal formuatlion. It was concluded by the CHMP that the benefits of calcitonin for osteoporosis did not exceed the risks. The nasal spray’s only indicated 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’s recommendations about calcitonin will go next to the European Commission, the executive branch of the European Union, for its final decision.