FDA警告：抗帕金森药物米拉帕可能增加心衰风险

圣路易斯(MD Consult)——2012年9月19日，美国食品药品管理局(FDA)发布了一条关于米拉帕(普拉克索)安全性的警示信息，这是一种用于治疗帕金森病和不宁腿综合征的药物。近期研究结果表明，使用米拉帕可能引发心衰风险，需要对现有数据做进一步评估。

FDA对一项纳入临床随机试验的汇总分析进行了评估，发现在使用了米拉帕的患者中心衰的出现频率高于安慰剂组，但差异无统计学意义。FDA还评估了来自2项流行病学研究的数据，这2项研究表明使用米拉帕与患者新发心衰的风险增加相关。

由于上述研究存在局限性，FDA尚无法确定使用米拉帕是否会增加患者出现心衰的风险。目前，FDA正在继续与生产商合作以进一步了解这一心衰风险，一旦获取了新的信息将及时向公众通报。

医生在开具米拉帕处方时应继续遵循产品说明中的使用建议，并提醒患者在服用米拉帕期间如果出现了心衰症状应及时就医。

FDA也鼓励医务人员和消费者将与使用米拉帕相关的不良事件上报至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 19, 2012, the US Food and Drug Administration (FDA) issued an alert concerning the safety of Mirapex (pramipexole), a drug used in the treatment of Parkinson's disease and restless legs syndrome. Results of recent studies suggest that use of Mirapex may pose a risk for heart failure, and that further review of available data is needed.

The FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure occurred more frequently with the use of Mirapex than with placebo; however, these results were not statistically significant. The FDA also evaluated data from 2 epidemiologic studies that suggested an increased risk of new onset heart failure with Mirapex use.

Because of study limitations, the FDA was not able to determine whether Mirapex use increases the risk of heart failure. The agency is continuing to work with the manufacturer to clarify further the risk of heart failure and plans to update the public when more information is available.

Prescribers of Mirapex should continue to follow the recommendations for use as specified in the drug label. Patients should be counseled to seek medical attention if they experience symptoms of heart failure while taking Mirapex.

Health care professionals and consumers are encouraged to report any adverse events related to Mirapex use to the FDA's MedWatch Adverse Event Reporting Program.