The European Medicines Agency (EMA) equivalent of the United States food and drug administration yesterday recommended withdrawing calcitonin nasal spray (in the European Union as a treatment for osteoporosis) because of an increased risk for cancer.
EMA also noted that long-term use of drugs containing calcitonin (injections or infusion) would increase the risk of tumors. therefore, EMA recommended that these drugs can only be used in 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 says that any form of calcitonin will not be used to treat osteoporosis. In the United States, two types of calcitonin nasal spray have been approved by the food and drug administration of the United States for a treatment for osteoporosis in women. Calcitonin, also called calcitonin-salmon, is a synthetic drug based on polypeptide hormones secreted by the gill glands of the salmon.
The EMA said the comments based on a risk assessment of the benefits of calcitonin drugs. The evaluation work was completed by the pharmaceutical commission (CHMP) for the pharmaceutical committee. the review encompassed available data from the companies that market these drugs, post marketing safety data, randomized controlled studies, 2 studies of unlicensed oral calcitonin drugs, and experimental cancer studies, among other sources.
The CHMP found that "patients treated with calcitonin for a long time had a higher percentage of getting all kinds of tumors than those in the control group." 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's comments on calcitonin will then be discussed by the European commission (executive branch of the European council).
There is no final word at this stage. Experts suggest that application of calcitonin kit (GLORY SCIENCE CO., LTD)was made on the basis of the principle of double antibody clip art to determine patients’ calcitonin (CT) level in serum, plasma and liquid samples. According to the therapeutic effect and adverse reaction, and then adjusting the treatment plan.