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FDA修订多发性硬化症口服药芬戈莫德的标签

来源:环球医学编译    时间:2012年05月15日    点击数:    5星

5月15日消息 - 环球医学据悉,FDA表示,多发性硬化症药物芬戈莫德(Gilenya)与反应致死相关;具有某些心脏风险因素的患者不应服用这种口服药物。

去年出现了服用该药的死亡报告,FDA已承诺就此事进行调查。

FDA在周一宣布,该机构仍然不知道是否是芬戈莫德导致了该患者的死亡;但尽管如此,FDA还是在该药的标签中加入了新的禁忌症,并加入了在患者服药后加强监测的建议。

根据修订后的标签,下列患者不应服用芬戈莫德:

•过去6个月中发生过主要心血管事件,包括心肌梗死、不稳定型心绞痛、脑卒中、短暂性脑缺血发作、需要住院治疗的失代偿性心力衰竭,或是III / IV级心力衰竭。

•患有莫氏II型二度或三度房室心脏传导阻滞或病窦综合征,或有以上疾病病史,除非患者置入了心脏起搏器。

•基线QTc间期≥500毫秒。

•接受Ia类或III类抗心律失常药物治疗。

此外,FDA表示,对于具有心动过缓风险的患者或是发生心动过缓就会导致严重后果的患者,芬戈莫德给药后的监测时间应当长于之前建议的6小时。

FDA称,“延长的监测应当包括整夜的ECG连续监测。”

FDA列出了心动过缓的几个风险因素,包括既往在服用芬戈莫德之后出现过心动过缓,或是病情或其他药物可能会诱发心率减缓和/或QT间期延长。

另一项新的建议是,所有开始服用芬戈莫德的患者在首次服药后都应每小时检查心率和血压。

在2010年芬戈莫德获批时,心动过缓是其公认的副作用,但在去年报告了患者死亡之后,对该药的担忧越来越严重。

在该死亡病例中,患者还同时服用β-受体拮抗剂美托洛尔和钙拮抗剂氨氯地平。FDA指出,这些药物与心动过缓和心脏阻滞的风险增加有关。

该患者成功地完成了当时所推荐的6个小时监测,但在几个小时后死亡。

FDA在公布修订标签时表示,尽管芬戈莫德对心脏的影响通常发生在服药后6小时内,但其对心脏影响的峰值“在一些患者中可能延迟至首次服药后20小时。”

根据该公告,“FDA的结论是,对于服用芬戈莫德后6小时内心率低于45次/分的患者,或是服用芬戈莫德6小时后达到其个人最低心率者,出于谨慎,应当将监测时间延长至大于6小时,因为服药6小时后仍然有可能进一步心动过缓。”

FDA表示,如果患者在服用芬戈莫德时发生头晕、乏力、心悸或心跳不规律,他们应当告诉医生。(环球医学)

原文:

FDA Puts New Limits on Oral MS Drug

Reacting to a death associated with the multiple sclerosis drug fingolimod (Gilenya), the FDA said patients with certain cardiac risk factors should not take the oral agent.

The death was reported last year and the agency had promised to investigate it.

In an announcement on Monday, the FDA said it still didn't know whether fingolimod caused the patient's death, but nevertheless it was adding new contraindications to the drug's label, as well as a beefed-up recommendation for monitoring patients after dosing.

According to the revised label, the drug should not be taken by patients with any of the following:

• Major cardiovascular events within the past 6 months, including MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure

• History or presence of Mobitz type II 2nd- or 3rd-degree atrioventricular heart block or sick sinus syndrome, unless the patient has a pacemaker

• Baseline QTc interval of 500 ms or more

• Treatment with class Ia or III antiarrhythmic drug

In addition, the FDA said, patients at risk for bradycardia or who may suffer serious consequences if it develops should be monitored for longer than the previously recommended 6 hours after fingolimod dosing.

"Extended monitoring should include continuous ECG monitoring that continues overnight," the agency said.

The FDA listed several risk factors for bradycardia, including a previous history of it after taking fingolimod and conditions or other drugs that may predispose to slowed heart rate and/or prolonged QT interval.

Another new recommendation, applying to all patients starting on fingolimod, is that heart rate and blood pressure should be checked hourly after the first dose.

Bradycardia was a recognized side effect of fingolimod when it was approved in 2010, but concerns grew more serious after the patient death was reported last year.

In the fatal case, the patient was also taking the beta-blocker metoprolol and the calcium channel antagonist amlodipine. These drugs are associated with increased risk for bradycardia and heart blocks, the FDA noted.

The patient had successfully completed the 6-hour monitoring period recommended at the time, but died a few hours later.

In announcing the label revisions, the FDA said that a new review of clinical trial data showed that fingolimod's cardiac effects may peak "as late as 20 hours after the first dose in some patients," although they usually occur within 6 hours.

"FDA concluded that it would be prudent to extend the monitoring period beyond 6 hours in patients who experience a heart rate of less than 45 beats per minute in the first 6 hours, or in those who had their lowest heart rate at 6 hours post-dose, as further bradycardia is still possible after 6 hours," according to the announcement.

The agency encouraged patients to tell their doctors if they experience dizziness, tiredness, palpitations, or irregular heart beat while taking fingolimod.
 

相关链接:http://www.medpagetoday.com/Neurology/MultipleSclerosis/32675 

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