FDA发布警告，辉瑞戒烟药物Chantix可能诱发癫痫

美国FDA近日发布警告声明称，辉瑞的戒烟药物Chantix可能与癫痫发作有关。服药的病人若同时有酒精摄入，就可能会变得情绪激动或是诱发癫痫。

FDA表示，尽管在九月份就已经更新了产品说明书，但是现在发布声明是为了让患者重视这一变化，从而在医生开处方的时候加以考虑。

通常在药品标签变更的同时会做出这样的警告声明。

Chantix的化学名称是varenicline，是2006年批准的戒烟药物。FDA随后更新了药品标签，并且在黑框警告中强调了该药物在神经精神上的副作用，包括自杀意图、敌意和情绪激动等。

辉瑞曾经要求FDA撤销黑框警告，声称辉瑞自己的研究中并未发现Chantix与神经精神类副作用有关。而在十月份，FDA的一个咨询委员会建议保留黑框警告，直到有确切的证据表明该药物的安全性。

而黑框警告通常是代表某药物最严重的风险。

FDA近日声明称，过去FDA曾验证了许多Chantix安全性的试验，其中也包括辉瑞自己做的分析。这些研究都存在着局限性，导致相关机构无法得出可靠的结论。

目前辉瑞又开展了针对Chantix安全性的相关试验，据悉2014年Chantix的收益是6.74亿美元。试验结果预计在2015年年底之前可以得到。FDA宣布黑框警告会一直保留，直到该安全性实验结果公布。

原文 U.S. FDA warns of seizure， alcohol risk with Pfizer's Chantix

The U.S. Food and Drug Administration warned on Monday that Pfizer Inc's quit-smoking drug， Chantix， has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out.

The agency said it approved an update to the drug's label in September but issued the public notice to ensure patients are aware of the changes "and can consider this new information when making prescribing decisions."

Typically such warnings are made at the time of a label change.

Chantix， known chemically as varenicline， was approved in 2006. The FDA subsequently updated the label to include a warning， highlighted by a black box， of neuropsychiatric side effects， including suicidal thoughts， hostility and agitation.

Pfizer has asked the FDA to remove the black box， saying its own studies show no association between Chantix and severe psychiatric side effects. In October an FDA advisory committee recommended keeping the black box pending the outcome of an ongoing safety study.

Boxed warnings are reserved for the most serious of risks.

The FDA said on Monday it had examined a variety of studies， including analyses conducted by Pfizer. The studies had limitations that prevented the agency from drawing reliable conclusions.

The company is conducting an additional safety study of the drug， which generated $647 million in revenue in 2014. Results of the trial are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.