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FDA issues alert about fraudulent of Botox in the US marketplace FDA针对美国市场上的假冒肉毒毒素发出警告  

2013-05-13 14:07:43|  分类: 默认分类 |  标签: |举报 |字号 订阅

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圣路易斯(MD Consult)——2013年4月26日,美国食品药品管理局(FDA)发布了一则警告,称假冒Botox正在美国市场上流通。其外包装纸箱是伪造的,而内装的玻璃药瓶被标注为外国产Botox。这些产品目前正在由无资质的供应商销售,由于这些供应商并不属于美国合法供应链,因此FDA无法确定这些产品的制造、质量、储存和处理是否符合美国标准。这些假冒产品被认为是不安全的,应避免使用。


目前正在销售这些假冒版Botox的公司有Online Botox Pharmacy、Onlinebotox.com和Onlinebotox等3个名字。在警告发布时,该公司似乎并未在网络上销售其产品,而是采用广发传真的办法请求医务人员帮助其销售,售价通常低于FDA批准的产品。与其他很多销售假冒产品的公司的典型做法相似,Online Botox Pharmacy在向医务人寄发送产品时使用一个美国的回信地址,而实际上这些产品来自国外。


FDA批准的合法Botox注射剂(100 u/瓶)是由Allergan生产的,外包装纸箱和药瓶上标注的活性成分是肉毒杆菌毒素A。


FDA正在要求公众报告来自Online Botox Pharmacy或其他有问题来源的可疑Botox产品。此外,医务人员和患者应将与使用任何可疑药物相关的不良事件报告至FDA的MedWatch不良事件报告系统


ST LOUIS (MD Consult) - On April 26, 2013, the US Food and Drug Administration (FDA) issued an alert concerning fraudulent versions of Botox circulating in the US marketplace. The outer carton is counterfeit, whereas the vial inside is labeled as a foreign version of Botox. These products are being sold by unlicensed suppliers who are not part of the legitimate US supply chain, and the FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow US standards. These fraudulent products are considered unsafe and should not be used.


The company selling the fraudulent versions of Botox goes by the names Online Botox Pharmacy, Onlinebotox.com, and Onlinebotox. At the time this alert was issued, the company did not appear to be selling its products via the Internet. Instead, the company has been using a process known as blast faxes to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a US return address when sending packages to medical practices, though the products are from foreign sources.


The legitimate FDA-approved Botox for injection (100 u/vial), manufactured by Allergan, displays the active ingredient as OnabotulinumtoxinA on the outer carton and vial. Currently, Allergan's FDA-approved version is not considered at risk, and this product should be considered safe and effective for its intended and approved uses.


The FDA is asking the public to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources to its Office of Criminal Investigations. In addition, health care professionals and patients should report adverse events related to the use of any suspect medications to the FDA's MedWatch Adverse Event Reporting Program.


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