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Doctor G 3 のメディカル・ポプリ

地域医療とプライマリケア、総合診療などに関係したネット上のニュースを記録。医学教育、研修、卒後キャリア、一般診療の話題、政策、そしてたまたまG3が関心を持ったものまで。ときどき海外のニュースも。

米国、製造過程の問題で薬剤回収/GSKとファイザー

GSK プエルトリコ工場での不良品
http://www.nytimes.com/2010/10/27/business/27drug.html?_r=1&ref=health
Glaxo to Pay $750 Million for Sale of Bad Products
By GARDINER HARRIS and DUFF WILSON
Published: October 26, 2010

GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant ― the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.
Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.
Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.
(後略)

ファイザー リピトール製剤で異臭
http://www.latimes.com/business/nationworld/wire/sns-ap-us-pfizer-recall-lipitor,0,6638007.story
Pfizer issues 3rd recall of cholesterol medicine Lipitor this year due to unpleasant odor
MATTHEW PERRONE AP Business Writer
October 29, 2010|9:40 a.m.
WASHINGTON (AP) ― Drugmaker Pfizer Inc. announced Friday it would recall 38,000 bottles of its blockbuster cholesterol drug Lipitor due to an unpleasant odor, the third recall this year related to the problem.
The New York-based drugmaker said the latest recall was triggered by two consumer complaints about a musty or moldy odor on Lipitor bottles, which are made by an outside company in Puerto Rico.
Pfizer has recalled over 360,000 bottles of Lipitor in the last three months because of the issue. The company recalled 140,000 bottles in August and another 191,000 earlier this month.
(後略)
  1. 2010/10/31(日) 05:20:33|
  2. 未分類