【外媒】安进因注射器纤维、聚酯污染召回Aranesp

仲夏秋夜云

小编：安进开始召回了。除了美国以外14个国家的Aranesp。我没看明白新闻。如果是注射器材质问题，或者说是产品和包材的相溶性问题，那么为啥美国的不召回？也许是因为销售权的问题，可能美国本土不是他销售的，没有市场开发权？知道的坛友请跟帖告诉小编
Aranesp是一种抗贫血药物。用于治疗慢性肾功能衰竭所导致的贫血症。
以下是新闻稿：

Amgen recalls Aranesp syringes contaminated with polyester

August 14, 2014 | By Eric Palmer
Amgen is voluntarily recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's ($AMGN) manufacturing operations, which were just targeted for big cuts as part of CEO Robert Bradway's effort to prepare the company for future competition to a key product.
The Thousand Oaks, CA-based biotech said that a single lot of 500-mcg prefilled syringes of Aranesp was repackaged into 9 lots that were then shipped to Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and the U.K. In a call Tuesday, company officials said that 15,880 syringes were included in the retrieval, MarketWatch reports.
The company issued the alert after a small number of the prefilled syringes were found to be contaminated with particles of cellulose, polyester, or both that were discovered during routine testing. It didn't say if it had discovered the source of the contamination.
Amgen said the risk of adverse reactions is small and none have yet been reported, but it said that if the particles were injected, they could cause an allergic reaction or potentially be fatal. Aranesp is used to treat anemia in patients with chronic renal failure, including those on dialysis, as well as some patients with nonmyeloid malignancies who are receiving chemotherapy. It said problems would vary depending on the route of administration, size of the particles, the medical condition of the patients and "the presence of a right-to-left cardiac shunt."
The recall comes at a difficult time for the company's manufacturing operations. Amgen announced in July that it will cut 12% to 15% of its workforce of 20,000, and roughly 15% to 20% of those cuts will be made in its manufacturing operations. It also said it will close or sell facilities in Washington and Colorado. About 50 manufacturing jobs in Washington state and 430 in Colorado will be lost, most by next year. The cuts are part of an effort to prepare for biosimilar competition to Amgen's top seller, arthritis drug Enbrel.

yuansoul

楼主很幽默

9v18

不认识安进

syhorchid

了解一下