缬沙坦全球召回事件已波及日本全球或迎来降压药短缺

2019-02-22 周亦川编 / 袁月狐大医

据fiercepharma网站报道，降压药缬沙坦的全球召回现在已经扩大到日本，药品原料药来自于印度。辉瑞在日本东京子公司的一份声明中指出，由于含有潜在的致癌物质，他们从上周四起召回了五批联合降压药物Amubaro。这是一种缬沙坦和苯磺酸氨氯地平的组合药，由麦兰公司在印度工厂生产。据称，在去年中国浙江华海制药公司的缬沙坦原料药爆出受到污染风波之后，该公司调查了自家的产品，查出含有致癌物N -亚硝基二

据fiercepharma网站报道，降压药缬沙坦的全球召回现在已经扩大到日本，药品原料药来自于印度。

辉瑞在日本东京子公司的一份声明中指出，由于含有潜在的致癌物质，他们从上周四起召回了五批联合降压药物Amubaro。这是一种缬沙坦和苯磺酸氨氯地平的组合药，由麦兰公司在印度工厂生产。据称，在去年中国浙江华海制药公司的缬沙坦原料药爆出受到污染风波之后，该公司调查了自家的产品，查出含有致癌物N -亚硝基二甲胺( NDMA )和N -亚硝基二甲胺( NDEA )。

声明指出，根据2018年11月9日日本厚生劳动省设定指标，以缬沙坦每日最大剂量160毫克计算，NDMA限度为0.59ppm，而NDEA是0.166ppm（ppm为百万分之一浓度）。此次的两批原药缬沙坦含有超过管理指标的0.20ppm及0.23ppm，也查出含有低于要求的0.10ppm的NDMA。但是，由于不能否定这两类物质存在的致癌风险，因此将五批产品均进行了召回工作。迄今为止没有健康受损的报告。

缬沙坦含致癌物事件可谓掀起轩然大波。事发后，美国FDA发现在某些缬沙坦原料药的生产环境中会产生NDMA和NDEA，包括溶剂再利用过程时混入的一些成分会导致缬沙坦原料药中产生诱变杂质，远远超过安全水平，这是该机构以前完全没有意识到的问题。FDA发现，在连续四年每天服用320毫克召回批次中缬沙坦使用者中， 8000人中可能有一个癌症病例。虽然风险不高，但不能忽视。

起初FDA在一封警告信中猛烈抨击华海制药公司改变其生产流程，后来发现在Aurobindo、麦兰，山德士、特瓦和其他公司的成品中均发现这种物质，这一发现引发了数百种缬沙坦、厄贝沙坦、氯沙坦的生产商进行全球召回动作。

麦兰对印度制造的缬沙坦原料药召回始于去年11月，共有15批NDEA超标的药物被回收。随后特瓦公司召回了使用此类污染的原料药生产的所有批次的缬沙坦成品。12月，麦兰将召回范围扩大，将所有缬沙坦产品都包括在内。今年1月，Torrent制药公司第二次扩大了氯沙坦和氯沙坦的联合药物召回。

全球大范围召回之后伴随着降压药的短缺，麦兰公司表示已经没有缬沙坦供应，诺华的山德士公司同样没有产品供应。FDA在药品对消费者构成的危险进行深入调查后，试图平衡药品暴露和停药之间的关系。在1月发布的一份声明中，FDA专员Scott Gottlieb指出，缬沙坦药物目前已经到了短缺状态，其他降压药将随即进入短缺状态，建议给出NDMA和NDEA两种杂质的安全范围指导用药。如果超标意味着癌症风险高，而安全范围内杂质带来的风险通常很小，停药比继续用药的风险要大很多。同时，FDA还给出了两种杂质的规避和测试方法的建议。

Gottlieb指出，高血压患者应该继续用药，甚至是召回范围的产品，直至药剂师提供替代品或医生提供替代治疗的方案。

参考资料：

https：//www.fiercepharma.com/manufacturing/pfizer-japan-finds-impurities-its-valsartan-drugs-made-by-mylan

https：//www.pfizer.co.jp/pfizer/company/press/2019/2019_02_08.html

https：//www.fiercepharma.com/manufacturing/fda-s-aggressive-move-tainted-sartan-leads-to-shortages

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2019-02-24 经常头晕

#降压#

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2019-02-24 chentianping

#日本#

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2019-02-24 medscijoin

#缬沙坦#

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2019-02-24 doctorzheng

#召回#

41 0
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2019-02-24 liuxiaona

#短缺#

34 0

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