降钙素可增加患癌风险，FDA及EMA建议撤市

Calcitonin Linked to Cancer Risk, EMA Warns
研究者认为：癌症患者高钙血症绝对不可以被使用！！！

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.

小学差点没毕业看不懂来个中文的

欧洲药品管理局（EMA）警告：降钙素存在致癌风险

       2012 年7月20日，相当于美国食品和药物管理局（FDA）的欧洲药品管理局（EMA）于7月19日建议撤回降钙素鼻喷雾剂（主要用于治疗骨质疏松症），因为它增加癌症发生的风险。

       欧洲药品管理局（EMA）也表示，长期使用含有降钙素的注射液或输液药物会增加患癌症的风险。因此，EMA 批准这些药物只在以下三种情况下可短期使用：佩吉特氏病，突然制动造成的急性骨损失以及由癌症引起的高钙血症。

       降钙素在任何情况都不应该用于治疗骨质疏松症，该机构认为。

       在美国，FDA批准两种降钙素鼻喷雾剂用于治疗妇女绝经后骨质疏松症，分别是Fortical（Upsher-Smith实验室）和Miacalcin（Novartis公司）。这两种药物的标签里都包含药物该如何使用及增加癌症风险的警告 。

       降钙素也叫鲑鱼降钙素，是鲑鱼鳃腺分泌的一种多肽激素的合成物。

       EMA认为此建议是介于降钙素的药效与风险审查的基础上提出的，由欧洲人用药物委员会（CHMP）进行审查，涵盖了从此类药物销售公司数据、上市后的安全数据、随机对照研究的数据、口服降钙素药物的研究和癌症研究的现有数据以及其他来源。

       CHMP发现“与服用安慰剂的患者相比，长期使用降钙素治疗的患者发生不同类型的癌症的比例较高。” 鼻喷雾制剂及口服制剂的致癌率从0.7％至2.4％不等。CHMP的结论是降钙素治疗骨质疏松症的获益低于风险。降钙素的鼻喷雾制剂的唯一适应症是骨质疏松症，从而证明该药物将被移除市场。
      
       EMA说，为防止突然制动导致的急性骨质流失，应用降钙素注射液或输液一般不应超过4周，治疗佩吉特氏病一般不超过3个月。该机构并没有指定将降钙素短期用于治疗由癌症引起的高钙血症的使用时间窗。

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学习了。英语翻译的不错~~