据美国食品和药物管理局( FDA)和欧洲药品管理局( EMA)的通知，治疗糖尿病的药物罗格列酮(商品名文迪雅)将在欧洲撤市，在美国获得该药需遵循严格的、新的要求。

FDA和 EMA的报告总结指出，有显著的证据表明，对于大部分患者来说，罗格列酮的心血管危险要高于其益处。美国的患者在使用其他药物血糖控制不佳时可使用该药，临床医师给患者处方该药时需谨慎权衡。已经使用罗格列酮且希望继续使用该药的患者，应当签署知晓相关危险的声明。目前美国约有 60万患者正在服用罗格列酮，预期这一数目将显著下降。该药是最受欢迎的糖尿病治疗药物之一，但其仍遭到审查和对其安全性的争论。科学家们在平衡药物危险和患者需求方面的意见有所差异。据悉，美国和欧洲药品管理机构在对罗格列酮进行回顾的整个过程中有密切接触，但最终意见的分歧可能与包括调控过程的差别在内的许多因素相关。美国糖尿病学会( ADA)和其他组织认为美国的决定是合理的折中办法。

FDA安排了罗格列酮制造商葛兰素史克公司召集科学家独立组回顾病例研究，该研究将罗格列酮与标准的糖尿病治疗药物的安全性进行了比较。此外， FDA还停止了 Tide研究，该研究对罗格列酮和吡格列酮(艾可拓)以及标准的糖尿病治疗药物进行了比较。

原文链接：

http://www.diabetes.org/news-research/news/diabetes-in-the-news/regulators-apply-brakes-on.html

Regulators Apply Brakes on Avandia

by Rob Stein September 24, 2010

The diabetes drug rosiglitazone (Avandia) will be withdrawn from the European market, and it will only be available in the United States under strict, new requirements, according to a coordinated announcement from the U.S. Food and Drug Administration (FDA) and European Medicines Agency.

These two groups concluded that there was significant evidence that rosiglitazone\'s cardiovascular risks outweigh its benefits for most patients. U.S. patients will be allowed to take rosiglitazone only as a last resort for blood-sugar control, and physicians will have to justify their decision to prescribe the drug. Patients who are already taking rosiglitazone and who wish to continue doing so must sign statements that they understand the risks involved. In the United States, about 600,000 people currently take rosiglitazone, but this number is expected to decline significantly.

Although it has been one of the most popular diabetes drugs, rosiglitazone came under scrutiny and debate over its safety.

Scientists have been divided over balancing the drug\'s risks with patient needs. U.S. and European officials reportedly have been in close contact throughout their reviews of rosiglitazone, with the difference in final decisions attributable to various factors, including differences in regulatory processes. The American Diabetes Association (ADA) and other organizations have called the U.S. decision a reasonable compromise.

The FDA has also ordered rosiglitazone manufacturer GlaxoSmithKline to convene an independent group of scientists to review the Record study, which compared the safety of rosiglitazone to standard diabetes drugs. In addition, the FDA has halted the Tide study, which compares rosiglitazone to pioglitazone (Actos) and to standard diabetes drugs.

Washington Post (09/24/10)