辉瑞未能说服FDA专家委员会删除戒烟药Chantix药品标签中的黑框警告

辉瑞未能说服FDA专家委员会删除戒烟药Chantix药品标签中的黑框警告

                               
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发布日期：2014-10-19  来源：生物谷  

FDA专家组认为Chantix的副作用令人担忧，应该保留黑框警告，该意见与2天前FDA内部审查意见一致。

                               
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专家委员会指出，辉瑞对来自第三方观察研究的分析数据，并没有包括Chantix所有的心理副作用。该委员会表示，衡量一种药物，除了考虑患者本人，还要考虑到对患者身边其他人员的潜在危害，而Chantix的明显副作用实在令人担忧。不过，业界认为，Chantix保留黑框，并不会对辉瑞2014年的销售和利润产生影响，该公司有14个药品在2014年的销售好于去年。

本周四，FDA专家委员会召开会议，就是否应该删除Chantix黑框警告展开讨论，该黑框警告告诫消费者Chantix可能导致一些严重的精神疾病甚至自杀。与会的大多数专家投票认为，应该继续保留Chantix的黑框警告。这一意见与2天前FDA内部审查员的意见一致。

专家委员会一致同意，待辉瑞完成Chantix上市后研究并提交数据后，再来讨论是否可以删除Chantix的黑框。目前，辉瑞正在一项涉及多大8000人的对照研究，比较Chantix与另外2种戒烟药和一种安慰剂的严重神经心理副作用。该研究的数据，预计将在2015年第三季度获得。辉瑞预计，该项研究的数据将支持Chantix的安全性。

辉瑞全球创新药品业务高级副总裁Steve Romano周三接受路透社记者采访时表示，希望该研究的数据能够证实公司所已经掌握的信息。

Chantix是辉瑞最有争议性的药物之一，拥有多种研究副作用，包括自杀念头、行为举止古怪、嗜睡。Chantix（通用名：varenicline，伐尼克兰）是一种非尼古丁戒烟处方药，于2006年在美国上市，成分主要是一种选择性烟碱乙酰胆碱受体部分激动剂。

FDA于2009年在Chantix药物标签中增添了一个黑框警告，强调了该药的的不良神经精神影响。“黑框”是置于处方药标识中最严重的一种警告,使用黑框也意味着禁止直接对消费者进行广告宣传。

美国国家健康研究中心（NCHR）是提交公民请愿书的5个非营利组织之一，要求FDA在Chantix黑框警告中纳入攻击/暴力、精神病、抑郁症风险。

英文原文：FDA panel votes to keep severe warning on Pfizer anti-smoking drug

Oct 16 (Reuters) - Pfizer Inc failed to convince the U.S. Food and Drug Administration to remove a black box warning on its controversial quit-smoking drug Chantix, with an advisory panel to the agency voting against the removal on Thursday.

A majority of the panel voted to keep the health regulator's most severe warning label on the treatment, in keeping with the recommendations of FDA staff two days earlier.

The panel agreed to revisit its stance on the warning label once data from Pfizer's post-marketing study of Chantix is available.

Pfizer is currently conducting a study on 8,000 people comparing Chantix's serious neuropsychological side effects with two other smoking-cessation treatments and a placebo. Data from the study is expected in the third quarter of 2015.

The company expects this data to support Chantix's safety profile.

"I'm hoping the data confirms all the information we already have today," Steve Romano, senior vice president of Pfizer's Global Innovative Pharmaceutical Business, told Reuters on Wednesday.

Chantix, also known as varenicline, is one of Pfizer's most controversial drugs and has a number of severe side effects, including suicidal thoughts, erratic behavior and drowsiness.

The FDA placed a black box warning - its most severe and restrictive warning - on the product in 2009, highlighting the drug's adverse neuropsychological effects.

The panel pointed out that data from Pfizer's analysis of third-party observational studies did not include all of Chantix's psychological side effects.

"Another factor into how the drug is weighed is that there may potential harm not just to the person taking the drug but people around them," a panel member said.

Diana Zuckerman, President of the National Center for Health Research (NCHR), called the drug's side effects "distinctly worrisome".

The NCHR is one of five not-for-profit organizations that had filed a citizen petition asking the FDA to include risks of aggression/violence, psychosis and depression in the black box warning.

The retention of the warning label is not expected to have an impact on Pfizer's sales or profits, analysts had said. The company had 14 drugs that had better sales than Chantix in 2013.

Pfizer shares closed down 1.7 percent at $27.70 on the New York Stock Exchange on Thursday. (Reporting by Vidya L Nathan in Bangalore; Editing by Simon Jennings)

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