FDA: Weight-Loss Drug Could Cause Suicidal Thoughts
减肥药可能引起自杀念头
Posted by Jacob Goldstein
Sanofi-Aventis’s drug Acomplia helps patients lose weight but appears to increase the risk of psychiatric side effects, including suicidal thoughts and behaviors, according to FDA documents published online today in advance of an upcoming meeting.
今天在网上提前公布了FDA将要在会议上公布的文件:Sanofi-Aventis公司的减肥药Acomplia有增加精神病风险的副作用,如引起自杀念头和自杀行为。
A committee of outside experts convened by the FDA is scheduled to gather Wednesday to hash out the risks and benefits of the drug, which has been approved in Europe.
FDA召集成立的一个由外界专家组成的委员会准备在周三召开会议,讨论此药的风险和利益,目前此药已经在欧洲获得了批准。
The FDA has yet to approve the drug, citing concerns that it appears to cause psychiatric problems in some patients. Members of the committee will vote on whether they believe the drug increases suicidality and other psychiatric problems, whether the drug should be approved, and whether there should be any specific warnings associated with the drug.
FDA尚未批准此药,据说是因为它可能在一些病人中引起精神问题。届时委员会成员将对以下问题进行投票:他们是否相信这种药有增加自杀和其他精神问题的风险,该药是否应该获准,对此药是否应该有相关的警告。
A few years back, Acomplia was eagerly anticipated on both sides of the Atlantic, with hopes that it could not only help obese patients lose weight but also help smokers quit. But psychiatric side effects have cooled reception to the drug in Europe and delayed its approval here.
几年前,世界各地对Acomplia抱有很大的期望,认为它不但能够有助于减肥,而且对戒烟也有很大的帮助。但是精神问题的副作用使它在欧洲受到冷落并且延迟在这里的获准时间。
Even the drug’s name has been problematic ― if it’s approved, Sanofi will call it “Zimulti,” in the U.S. because the FDA ruled that the name “Acomplia” could be “too descriptive or eventually misleading,” according to a Sanofi exec.
药名也是一个麻烦――Sanofi的一个董事说如果在美国获得批准,Sanofi将把它改名为Zimulti。
因为FDA认为Acomplia这个名字可能会误导大众。
In its own document released for the committee meeting, Sanofi lays out several steps it would take to manage the drug’s risks. And the company argues that the health benefits for patients who lose weight with the drug would outweigh the risks.
Sanofi在委员会会议上公布了他们的文件,列举了他们针对这些风险将要采取的措施。公司强调对减肥者来说,用此药利大于弊。
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减肥药

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