ST LOUIS (MD Consult) - On May 26, 2010, the US Food and Drug Administration (FDA) announced that new safety information related to rare cases of severe liver injury is being added to the labels for the weight-loss drugs Xenical and Alli. Severe liver injury has been reported in 1 person from the United States who took Alli and in 12 persons from foreign countries who took Xenical. Some of these cases resulted in liver transplant or death. The FDA decided a label update was warranted because of the severity level of injuries reported.

Xenical and Alli contain different strengths of the same active ingredient, orlistat. Xenical is sold by prescription and Alli is offered over-the-counter. According to the FDA, an estimated 40 million persons worldwide have taken either Xenical or Alli.

Some patients in the 13 referenced cases were taking other drugs or experienced other conditions that may have contributed to the development of severe liver injury. The decision to include information about hepatic injury in the drug labels was made after completion of the FDA's comprehensive review of all available data (preclinical, clinical trial, postmarketing, and drug utilization) on severe liver injury associated with Xenical through August 7, 2009, and a review of postmarket data on Alli through October 1, 2008.

At this time, a cause and effect relationship between severe liver injury and orlistat use has not been established.

Health care professionals should instruct patients taking Xenical or Alli to report any symptoms of hepatic dysfunction (eg, anorexia, pruritus, jaundice, dark urine, light-colored stools, and right upper quadrant pain). If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and hepatic testing should be performed. Any adverse events associated with the use of Xenical or Alli should be reported to the FDA's MedWatch program.

圣路易斯(MD Consult)——2010年5月26日，美国食品药品管理局(FDA)宣布，因发生少数几例重度肝损伤事件，减肥药赛尼可(Xenical)和阿莱(Alli)的产品说明书中将补充相关的安全性信息。据报道，美国1位阿莱服用者和美国以外其他国家12位赛尼可服用者发生了重度肝损伤。其中某些病例导致肝移植或死亡。鉴于所报道的损伤程度为重度，FDA决定敦促其生产厂家更新产品说明书。

 

赛尼可和阿莱包含同一种有效成分奥利司他，具有不同规格。赛尼可以处方药形式出售，阿莱为非处方药。据FDA称，估计全世界有4,000万人服用了赛尼可或阿莱。

所指的这13例病例中有些在服用其他药物或发生其他情况，而这些情况可能导致重度肝损伤的发生。FDA在对2009年8月7日以来与赛尼可相关的重度肝损伤的所有可用数据(临床前、临床试验、上市后以及药物应用后的数据)以及2008年10月1日以来阿莱上市后的数据完成全面审核后决定在其产品说明书中补充肝损伤信息。

目前，重度肝损伤与使用奥利司他之间的因果关系尚未得到证实。

医护人员应指导服用赛尼可或阿莱的患者报告肝功能不全的任何症状(如恶心、瘙痒、黄疸、尿液颜色加深、粪便色浅及右上腹疼痛)。若疑似肝损伤，则应立即停用奥利司他或可疑药品，并应进行肝功能检查。任何与使用赛尼可或阿莱有关的不良事件均应报告至FDA's MedWatch项目。