Consumer Update

New Safety Information on Diabetes Drug Rosiglitazone

罗格列酮的新的安全信息

Do not stop taking Avandia, Avandaryl or Avandamet without first talking to your doctor about this new information.

如果没有首先与您的医生商量此新的安全信息，不要停止服用文迪雅，文迪锐或文迪美。

This update was revised on June 18, 2007, to include information about the FDA's upcoming open public advisory committee meeting regarding rosiglitazone

此信息修订于2007年6月18日，包括FDA预定举行的关于罗格列酮心脏病风险可能性的公开顾问委员会会议的信息。

Concerns are being raised about a possible increased chance of heart attack and heart-related deaths in patients taking rosiglitazone, an ingredient in three drugs used to treat type 2 diabetes: Avandia, Avandaryl, and Avandamet.

What Patients Should Do患者应当做什么？

If you are a patient taking rosiglitazone:

Do not stop taking Avandia, Avandaryl or Avandamet without first talking to your doctor about this new information. 如果没有首先与您的医生商量此新的安全信息，不要停止服用文迪雅，文迪锐或文迪美。

Discuss the best individualized treatment plan for your diabetes and other medical conditions. 讨论针对您的糖尿病和其它疾病的最佳个体化治疗方案。

Remember that the best treatment plan is a team approach between you and your doctor. 牢记最佳的治疗方案由您和您的医生共同达成。

There is agreement by several organizations that the overall level of risk appears to be small, but that the risk deserves serious attention and follow-up. They are:以下这几个机构认为总体风险水平显得很小，但这种风险值得重视和随访：

American Association of Clinical Endocrinologists 美国临床内分泌学家协会

American College of Cardiology 美国心脏病学学院

American Diabetes Association 美国糖尿病协会

American Heart Association 美国心脏病协会

Endocrine Society 内分泌会

FDA agrees with these organizations and is conducting a thorough investigation.FDA认可这些机构进行彻底的调查研究。

What We Know我们已经知道什么

FDA and GlaxoSmithKline (GSK), the maker of rosiglitazone, have long recognized that use of drugs containing this ingredient may be associated with certain heart problems. This information has been included in the prescribing information for all rosiglitazone-containing products since 2001.

FDA和葛兰素史克（GSK）从2001年起就已经认可罗格列酮的的某些心脏问题，这些信息已经包含在所有含罗格列酮产品的处方资料里。

New information regarding fluid-related heart problems has been updated since 2001 and included in the prescribing information for all three drugs--most recently in 2006.

关于水肿相关的心脏问题的新信息，从2001年直至最近的2006年就处于不断更新之中，而且已经包含在所有含罗格列酮产品的处方资料里。

GSK combined the data from 42 clinical studies to look at the chance of other heart problems with rosiglitazone, analyzed the data, and submitted the results of this analysis to FDA, which is conducting its own analysis of these data.

These combined data raise the possibility of a new risk from rosiglitazone, related to the heart. This possible risk, while important, appears to be small.

There are over 14,000 people in these studies, and about 2/3 of them were treated with rosiglitazone.

Rosiglitazone is in a class of drugs called thiazolidinediones (TZDs). The other approved drug in this group is pioglitazone (Actos). These are two different drugs, and FDA is evaluating whether they have the same or different heart-related risks.

Swelling and fluid retention may occur with both drugs, so neither should be used in patients with troublesome heart failure.

What FDA is Doing FDA正在做什么？

Conducting its own analysis of GSK's combined data, including a detailed review of the patient information from the 42 studies.

对GSK的合并数据进行分析，包括来自42个研究的患者信息的详细回顾。

Considering the results of these data along with all other published and unpublished studies regarding rosiglitazone use and other diabetes drugs to determine the chance of heart problems.

考虑所有公布和未公布的罗格列酮研究和其它糖药的数据结果，以确定心脏问题。

Continuing to update the public as the agency receives new information, completes its analyses, and reaches conclusions based on those analyses.

继续根据接收到的资料更新公众信息，完成分析，并从这些分析中得出结论。

Type 2 Diabetes:

Is a serious and life-threatening disease

Affects about 18 to 20 million Americans

Is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation

Is usually treated first with diet and exercise, and if they are not enough, FDA-approved medications, including metformin, sulfonylureas, thiazolidinediones, insulin, and several newer drugs, to lower blood glucose levels

Differs among each person, so treatment must be individualized.

由于每个人都不同，因此治疗必须个体化。

Advisory Committee Meeting – July 30, 2007 (Open to the Public)顾问委员会会议—2007年7月30日（对公众开放）
The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet to discuss the cardiovascular ischemic and thrombotic (heart-related) risks of thiazolidinediones, focusing particularly on rosiglitazone (Avandia). For more information, visit www.fda.gov/OHRMS/DOCKETS/98fr/E7-10850.htm

内分泌和代谢药物顾问委员会以及药品安全和风险管理顾问委员会将开会讨论噻唑烷二酮类心血管缺血和血栓形成（心脏相关）的风险，特别是罗格列酮（文迪雅）。

Date Posted: May 25, 2007
Updated: June 18, 2007

数据更新：2007年6月18日