ST LOUIS (MD Consult) - On August 24, 2009, The US Food and Drug Administration (FDA) issued an early communication about an ongoing safety review of the drug orlistat, a product marketed under the brand names Alli and Xenical. The FDA is investigating reports of liver-related adverse events received through its Adverse Event Reporting System.

Xenical (orlistat 120 mg) was approved as a prescription product in 1999 for obesity management in conjunction with a reduced caloric diet, and as a means to reduce the risk of regaining weight after weight loss has occurred. In 2007, Alli (orlistat 60 mg) was approved for over-the-counter use as an aid to weight loss in overweight adults, in conjunction with a reduced-calorie and low-fat diet.

Between 1999 and October 2008, 32 reports of serious liver injury in patients using orlistat, including 6 cases of liver failure, were received by the FDA's Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the reports of serious liver injury were jaundice, weakness, and abdominal pain. Hospitalization was reported in 27 cases.

The issue of liver safety with orlistat was discussed at the April 2009 meeting of the drug safety oversight board for the FDA's Center for Drug Evaluation and Research. In addition to the aforementioned 32 adverse events, also being reviewed were reports of other suspected cases of liver injury that had been submitted by the manufacturers of orlistat.

At this time, the FDA's analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established. The agency is considering whether this information warrants any regulatory action.

The FDA is not advising health care professionals to change their prescribing practices with orlistat. In addition, the agency is advising consumers currently taking Xenical to continue taking it as prescribed, and it recommends that those taking Alli continue using the product as directed.

Patients taking orlistat should be advised to seek medical consultation if they experience signs or symptoms that may be related to liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other manifestations of possible liver problems that may evoke concern include abdominal pain, nausea, vomiting, light-colored stools, pruritis, or loss of appetite.

The FDA urges health care professionals and consumers to report adverse effects from the use of orlistat to its MedWatch Adverse Event Reporting program online, by telephone (1-800-332-1088), by fax (1-800-FDA-0178), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

 

圣路易斯（MD Consult）——2009年8月24日，美国食品药品管理局（FDA）发布了一项警示，宣布当局正对奥利司他的安全性进行审查，该药市售商品名为Alli和赛尼可。FDA正在调查其不良事件报告系统收录的肝脏相关不良事件报告。

赛尼可（奥利司他，120mg）在1999年获准作为处方药与低卡路里膳食联用治疗肥胖，也获准作为降低减重后体重反弹风险的药物。2007年，Alli（奥利司他 60mg）获准作为非处方药联合低卡路里及低脂膳食用于超重成人减肥。

 

在1999年至2008年10月期间，FDA不良事件报告系统收到了32份服用奥利司他的患者发生严重肝损伤的报告，其中包括6例肝衰竭。32份报告中有30例发生于美国以外的其他国家。严重肝损伤报告中最常报告的不良事件为黄疸、虚弱及腹痛。报告中有27例患者住院治疗。

FDA药品评价与调查中心药品安全监督委员会在今年4月份的2009年年会上围绕奥利司他肝脏安全性这一主题进行了讨论。除了前述的32例不良事件外，还对其他疑似肝损伤报告也进行了审查，这部分报告系奥利司他生产厂家所提交。

当前，FDA对这些数据的分析仍在进行之中，尚未证实肝损伤与奥利司他之间存在明确的相关性。当局正考虑针对此信息是否应该采取调整措施。

FDA目前并不提倡医疗卫生专业人士改变奥利司他的处方惯例。此外，当局建议当前正在服用赛尼可的消费者继续按处方服用，而且还推荐服用Alli的人群继续按说明书服用。

应该建议服用奥利司他的患者在出现可能与肝损伤有关的症状和体征时，特别是在出现虚弱或疲劳、发热、黄疸或茶色尿时应进行相关医疗咨询。其他值得关注的可能肝损伤表现包括腹痛、恶心、呕吐、浅色便、瘙痒或食欲不振。

FDA敦促医疗卫生专业人士和消费者将使用奥利司他所致的不良反应报告至其MedWatch不良事件在线报告系统，可致电1-800-332-1088报告，或传真至1-800-FDA-0178，或者将邮资已付的FDA 3500表邮寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787。

 

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