ST LOUIS (MD Consult) - On January 18, 2010, the US Food and Drug Administration (FDA) issued a press release warning the public about a counterfeit and potentially harmful version of Alli 60-mg capsules (120-count refill kit) being sold to consumers. Alli is an FDA-approved over-the-counter weight-loss product containing the active ingredient orlistat. 

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), Alli's manufacturer, revealed that the counterfeit version did not contain orlistat, but instead contained sibutramine, a controlled substance. Sibutramine is the active ingredient in a prescription weight-loss drug known as Meridia. According to the Meridia product label, the drug acts by inhibiting the uptake of serotonin, norepinephrine, and dopamine. Alli acts by reducing the absorption of dietary fat. 

According to an FDA press release, sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Consumers are being warned that the use of sibutramine with other medications may lead to an unfavorable interaction. 

Reports of suspected counterfeit Alli began arriving at GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the Internet. At this time, no evidence has emerged showing that the counterfeit Alli product has been sold through other channels, such as retail stores. 

The counterfeit Alli product looks similar to the authentic product, with a few notable differences (listed below):  

• outer cardboard packaging is missing a "Lot" code;
• expiration date that includes the month, day, and year (eg, 06162010); the authentic Alli expiration date includes only the month and year (eg, 05/12);
• packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with the statement, "Sealed for your protection"; and
• contains larger capsules with a white powder, instead of small white pellets. 

Consumers who believe they have received counterfeit Alli are being asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site. In addition, health care professionals and consumers are being encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program. 

Pictures of counterfeit Alli samples provided by GSK are shown below:

圣路易斯(MD Consult)——2010年1月18日，美国食品药品管理局(FDA)召开新闻发布会，正式警告公众有一种伪造的、可能对健康有害的Alli 60mg胶囊(120粒替换装)正在面向消费者销售。Alli是FDA批准的一种非处方类减肥药，其有效成分为奥利司他(orlistat)。 

Alli生产商葛兰素史克公司(GlaxoSmithKline, GSK)初步实验室检测显示，这种仿冒品没有含奥利司他，而是含有一种限制使用的药品西布曲明。西布曲明是一种处方类减肥药Meridia中的有效成分。根据Meridia产品标签显示，这种药物是通过抑制5-羟色胺、去甲肾上腺素和多巴胺的摄取起作用的。Alli是通过减少食物中脂肪的吸收而起效的。 

根据FDA新闻发布会上的一份声明，西布曲明不应该用于某些患者群或在无医嘱情况下使用。需要警告消费者在同时使用西布曲明与其他类药物时可能出现一些不良反应。 

疑为Alli仿冒药品的报告于2009年12月初开始上报给GSK公司。GSK公司已经确定这种伪造药品在通过互联网销售。同时，尚无证据显示Alli仿冒药品通过其他渠道销售，如零售商店。 

这种Alli仿冒药品在外形上与真品类似，但有一些值得注意的不同之处(列举如下)： 

• 外部的硬纸壳包装上缺少批号编码；
• 仿冒品的使用截止期包括年、月和日(如：06162010)；真品的使用截止日期只有年、月(如：05/12)；
• 与真品比起来，仿冒药品的塑料瓶瓶盖稍高些、宽些，边缘较粗糙；
• 塑料瓶盖下内部纯铝箔安全封口上没有印任何文字；真品的封口上印有“Sealed for your protection”的字样；而且
• 真品中的胶囊更大些，内含白色粉末状物质；而仿冒品胶囊内含的是白色小颗粒状物质。            

消费者若认为自己购买了Alli仿冒品，可以拨打800-551-3989或访问OCI Web site网站，与FDA的犯罪调查办公室(OCI)联系。此外，也鼓励医护人员和消费者将服用这种仿冒药品的不良反应报告至FDA的药品监督网页系统(MedWatch Program)。 

GSK公司提供的Alli仿冒样品图片展示如下：