【英语国际】美药管局顾问同意糖尿病药文迪雅继续销售

A Food and Drug Administration advisory panel voted Wednesday to recommend keeping the diabetes drug Avandia on the market, but said it poses a 'significant safety' concern because it raises the risk of heart attacks.

It is now up to the FDA to make the final call on whether Avandia, made by GlaxoSmithKline PLC (GSK, GSK.LN), will remain on the U.S. market. The two-day meeting and the unprecedented question that it posed to its advisory panel indicate that agency leaders might begin demanding more safety data before new drugs are approved, analysts and researchers say.

FDA officials acknowledged that it was unusual for the agency to ask its advisory committee to directly compare the safety of one drug, in this case Avandia, with a rival medicine, Actos.

Twelve of the panel's 33 members voted to remove the drug, and most of those who supported keeping Avandia on the market said they wanted more restrictions on its use. Many said their vote to retain Avandia was based on the lack of hard evidence about potential harm, and they added Avandia should be used only if other diabetes' drugs don't work.

So for now, doctors and their patients still don't have a clear cut signal on what to do because advisory panels' decisions are nonbinding.

Both Avandia and Actos were approved in 1999 to lower blood-glucose levels for patients with Type 2 diabetes, which affects about 23 million Americans.

Heart failure from excess fluid retention has been a long-recognized problem with Avandia and Actos, and both products already carry the FDA's toughest boxed warning discussing that risk. The issue with Avandia is whether it raises the risk of heart attacks and cardiovascular problems more than other diabetes treatments.

周三，美国食品和药物管理局(The Food and Drug Administration, 简称FDA)一个顾问小组投票建议允许继续销售治疗糖尿病的药物文迪雅(Avandia)，但说由于此药提高了心脏病发作的风险，因此对其安全性表示严重关切。

现在轮到由FDA最终决定是否允许葛兰素史克公司(GlaxoSmithKline PLC)生产的文迪雅继续在美国销售。分析师及研究员说，为期两天的会议以及FDA给其顾问小组提出的前所未有的问题表明FDA的领导人或许在批准新药之前将开始要求更多的安全性数据。

FDA官员承认，对FDA而言，要求其顾问委员会直接比较两种竞争性药品（本案中是文迪雅和Actos）的安全性非寻常之举。

委员会的33名成员中有12人投票支持停售文迪雅，且大多数支持继续销售的成员说希望更严格地限制使用这种药物。许多人说他们投票支持继续销售文迪雅是由于缺乏与潜在危害有关的确凿证据，并说只有其它治疗糖尿病的药物不起效时才能使用文迪雅。

由于顾问小组的决定不具有约束力，因此目前医生和病人对该如何去做仍然没有明确的答案。

文迪雅和Actos约于1999年获批用于降低Ⅱ型糖尿病患者的血糖标准。约2,300万美国人患有Ⅱ型糖尿病。

体内摄取液体过多造成心力衰竭一直是文迪雅和Actos长期存在的问题，两种药品的药盒内均提供了FDA对这种风险提出的最严厉警告。文迪雅的问题在于，与其它的糖尿病治疗方法相比，它引发心脏病及心血管问题的风险是否更大。