After Vioxx and other safety controversies," the American people no longer trust the FDA to protect their health," said Nissen, who has served on FDA advisory panels. 发生了万络和其他安全争议问题之后,“美国民众不在相信FDA能够保护他们的健康,”就职于FDA顾问团的尼森说。
Merck has already turned over at least two million documents in the federal litigation, whose plaintiffs claim Vioxx caused heart attacks and other injuries. 默克公司已经在这一系列诉讼案中递交了两百万份文件,这些案件中的原告都指控万络给他们带来了心脏病和其他损伤。
The New Jersey-based drugmaker was sued by tens of thousands of former Vioxx users who claimed to have been injured by the arthritis medicine. 以新泽西为生产基地的默克公司被数以千计万络使用者控告,这些使用者声称他们在关节炎治疗中受到伤害。
The FDA requested the report in2004 after the agency was criticized as being lax in its oversight of Merck& Co Inc.'s arthritis drug Vioxx and other medicines. FDA需要在2004年做一个报告,当这个机构被指责对默克公司生产的治疗关节炎的万络和其他一些药物的监控疏忽。
The criminal charge arose out of the fact that Vioxx had also been promoted as a treatment for rheumatoid arthritis before being officially approved. 该药因被作为治疗关节炎的药物推销而被指控,而这种推销行为是在获得药品管理部门正式批准之前。
Vioxx was taken off the market in2004. 万络在2004年已经退出市场。
With Vioxx event as example, literature research methods were used to analyze the experiences that USA solves those problems. 以万络事件为例,采用文献研究方法,分析美国解决药品安全风险问题的经验。
The findings also support prior research linking rofecoxib ( Vioxx) with adverse cardiovascular effects. 该研究也支持以前关于罗非考昔(Vioxx)与心血管副作用相关的结论。
The FDA never ordered the drug withdrawn and a subsequent Advisory Committee did not recommend that Vioxx should be barred from returning to market. FDA从来没有命令药品召回,其下的咨询委员会也没有建议对万络重返市场设置阻碍。
Celebrex, in the same class of medicines as Merck's recalled Vioxx, is Pfizer's third-best-selling drug. 西乐葆使默克回想起同类的药物,也是在辉瑞第三畅销的药品&万络。
Compared to placebos, Vioxx and Prexige were associated with twice the risk of heart attack. 与安慰剂相比,万络和鲁米昔布高于其两倍的心脏病风险。
The civil suit accuses Merck of hiding information about the seriousness of the risks of heart attacks and strokes for patients taking Vioxx. 民事诉讼控告默克公司向服用万络的患者隐瞒了药物致心脏病发作及中风危险的严重性的信息。
The charge arose from Merck's promotion of Vioxx to treat rheumatoid arthritis before the Food and Drug Administration approved it for that purpose in2002. 此次控诉源于2002年默克制药公司对万络治疗类风湿性关节炎的虚假宣传,而美国食品和药品管理局事先并未批准万络用于类风湿性关节炎。
Vioxx was the subject of a worldwide withdrawal in2004 after a clinical trial indicated that it increased the risk of adverse cardiovascular side effects. 在临床实验证实万洛会增加心血管不良反应后,2004年万洛全球性停用。
Investors are also suing Merck, saying it played down the risks of Vioxx and cost them billions of dollars in stock value after the drug was removed from the market. 投资者也在起诉默克公司,称它轻描淡写了万络的风险,造成了他们的股票价值在药品从市场下架后蒸发了数十亿美元。
Then in2004, Merck withdrew its painkiller Vioxx after studies showed the pill increased the risk of heart attacks and strokes. 随后在2004年,在研究显示默克公司的止痛药万络增加了心脏病发作和中风的危险性后,该药撤出了市场。
The drug maker also said the journal article contained "numerous inaccuracies" and that its conclusions were based on a limited selection of documents produced in the Vioxx litigation. 默克同时称,该文章包含“很多不正确的地方”,并且该结论的依据仅局限于万络案中提供的一些文献资料。
Thus it is theoretically possible to treat people safely with Vioxx and other Cox-2 inhibitors if existing TF-blocking drugs are given simultaneously. 因此,对于病人服用万络或其他环氧化酶2抑制类药物,同时给予减少凝血激酶的药物治疗,理论上是安全的。
Those payments will settle civil claims that its illegal marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed. 这些赔偿将解决因非法销售该药导致医生开出本不该开的药物及政府为该药买单的民事赔偿要求。
Critics said the FDA should have reacted sooner to signs of problems related to Vioxx and other medicines on the market. 批评家们说FDA本应该早点对万络问题的迹象以及市场上其它的药物问题的迹象作出反应的。