ST LOUIS (MD Consult) - On September 23, 2010, the US Food and Drug Administration (FDA) announced that it has reached a decision about the continued marketing of the diabetes drug Avandia (rosiglitazone). Avandia is indicated for use by patients with type 2 diabetes whose glycemic control has been inadequate using other diabetes medications. The drug has recently been the subject of intense scrutiny because of cardiovascular safety concerns (eg, myocardial infarction and stroke).

 

A memorandum issued by Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, states that the drug will be permitted to remain on the market in a restricted capacity. The FDA is requiring Avandia's manufacturer, GlaxoSmithKline (GSK), to undertake a restricted access program under the agency's Risk Evaluation and Mitigation Strategy (REMS) initiative to include elements to ensure the safe use of the product. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

In addition to the REMS requirement, GSK must commission an independent readjudication of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes (RECORD) study. GSK is also being instructed to place the postmarketing trial known as Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) on full clinical hold.

In a summary statement, Dr Woodcock remarked that multiple and conflicting signals of cardiovascular ischemic risk exist in relation to rosiglitazone use. Despite the lack of clarity in the data, she believes it is most prudent, given the current uncertainty about the safety risk, to restrict access to the product, and ensure that patients and prescribers are fully informed of the evidence of risk, until and unless more information is obtained.

圣路易斯(MD Consult) – 2010年9月23日，美国食品药品管理局(FDA)宣布，糖尿病药物文迪雅 (Avandia，罗格列酮)可继续上市，用于使用其他治疗糖尿病药物无法完全控制血糖的2型糖尿病患者。该药最近因心血管安全性方面的担忧而接受了严格审查。

 

一份由FDA药物评价和研究中心主任Janet Woodcock博士签署的备忘录称，该药物将被允许继续上市，但限制其适用范围。FDA要求文迪雅生产商葛兰素史克(GSK)在“风险评估与降低战略（REMS）”中制定一项包括确保药品安全使用因素在内的限制药品获得措施。通过执行该REMS，仅当患者使用其他药物不能很好控制血糖和无法使用Actos (吡格列酮，另外一种同类药物)的情况下才能使用文迪雅。目前使用文迪雅且从中受益的患者，如果愿意可继续使用该药物。

 

除上述REMS要求之外，GSK必须成立一个独立专家委员会对“罗格列酮心血管预后评价及糖尿病血糖调节研究(RECORD)”进行重新评估，对其上市后“噻唑烷二酮及维生素D干预的评价(TIDE)”试验，也应全面停止。

Woodcock博士在一份简短声明中指出，缺血性心血管疾病风险与罗格列酮使用有关。尽管缺乏明确的数据，但鉴于目前安全风险的不确定性，她认为在获得更多信息之前，限制该药品使用及确保患者和处方医生全面获悉有关风险证据，是最为慎重的。