Sept. 28, 2018 -- The FDA on Friday moved to block all imports of drugs made with ingredients made by a Chinese plant at the center of a massive recall of heart and blood pressure medications.
The agency says Zhejiang Huahai Pharmaceuticals will be on what’s called “import alert” until it “fully determines how impurities were introduced into its API,” or active pharmaceutical ingredient, and fixes its quality systems.
“The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States.”
The move comes after the FDA recalled blood pressure and heart failure medicines because of the discovery of at least two potentially cancer-causing impurities.
Three lots of Torrent Pharmaceuticals’ valsartan drugs were found this month to contain NDEA, which is known to cause cancer in animals and is thought to be a human carcinogen.
Those drugs were already part of August’s recall of valsartan products for possible contamination with NDMA, another impurity that may cause cancer. More than a dozen brands of valsartan drugs are subject to the recall. For a full list, visit this FDA site.
According to the FDA, Zhejiang Huahai Pharmaceuticals discovered the NDEA in several batches of its valsartan ingredients.
European authorities in July also recalled drugs that had valsartan that were supplied by a Chinese drugmaker over concerns they may contain NDMA. More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent months.
If you take a valsartan drug for high blood pressure or heart failure, the FDA recommends you continue to take it until you can speak with your doctor or pharmacist. Even if your medication is part of the recall, the agency says continue to take it and consult your doctor for possible alternatives.
2018年9月28日——美国食品和药物管理局(FDA)周五采取行动，禁止进口由中国一家工厂生产的原料制成的药物。
国家质检总局表示，浙江华海药业将进入所谓的“进口预警”，直到“完全确定原料药(活性药物成分)中引入杂质的方式”，并修复其质量体系。
“进口警报将阻止ZHP生产的所有原料药和使用ZHP原料药生产的成品药品合法进入美国。”
此前，美国食品和药物管理局因为发现至少两种可能致癌的杂质而召回了血压和心力衰竭类药物。
本月，三批Torrent制药公司的缬沙坦药物被发现含有NDEA，这种药物在动物身上会致癌，被认为是一种人类致癌物。
这些药物已经是8月份召回的缬沙坦产品的一部分，可能被NDMA污染，NDMA是另一种可能导致癌症的杂质。十多个品牌的缬沙坦药物被召回。完整的清单，请访问FDA网站。
据FDA称，浙江华海制药公司(Zhe jiang Hua hai Pharmaceuticals)在数批次的缬沙坦(valsartan)成分中发现了NDEA。
欧洲当局7月份还召回了一家中国制药商供应的含有缬沙坦的药品，原因是担心这些药品可能含有NDMA。近几个月，20多个欧洲国家、加拿大和美国召回了缬沙坦药物。
如果你服用缬沙坦治疗高血压或心力衰竭，FDA建议你继续服用，直到你能与医生或药剂师交谈。即使你的药物是召回的一部分，该机构说，继续服用，并咨询你的医生可能的替代方案。
本文来源：https://www.webmd.com/heart/news/20180928/fda-bans-import-of-meds-from-chinese-firm
