ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine.

Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks.

"Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke."

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research Industries Inc (ALR Industries), Oak View, Calif. On December 24, 2008, ALR Industries initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only "trace amounts" of sibutramine were found in this product, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.

The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France, and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact the company at legal@alrindustries.com to receive further instructions for returning the product and to ask any questions.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online or by regular mail, fax, or phone.

• Online: www.fda.gov/MedWatch/report.htm.
  
   
• Regular mail: Use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
  
   
• Fax: (800) FDA-0178
  
   
• Phone: call (800) FDA-1088
  
   

For an updated list of all tainted weight loss products, go to www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html.
 

圣路易斯（MD Consult）——美国食品与药物管理局（FDA）警告消费者不要再服用Venom HYPERDRIVE 3.0，原因是这种作为膳食补充剂销售的产品含有西布曲明。

西布曲明是一种因存在滥用或成瘾危险而受管制的物质，也是一种具有潜在安全隐患的强效药物。

FDA药品评估与研究中心主任Janet Woodcock博士说，“西布曲明是FDA批准的一种通过抑制食欲来减肥的处方药的活性成分，但当其存在于膳食补充剂中时，可能会伤害不明真相的消费者，因为西布曲明可显著升高血压和增加心率（脉搏），从而给有心脏病、心力衰竭、心率失常或卒中病史的患者带来明显风险。”

Venom HYPERDRIVE 3.0是Applied Lifescience Research Industries公司（ALR Industries，Oak View，Calif）的上市产品。2008年12月24日，在FDA实验室分析得出该产品样本中含有未申明组分西布曲明后，ALR Industries发布了召回所有批次Venom HYPERDRIVE 3.0的召回令。尽管ALR Industries在其网站上宣称，该产品中仅含有“痕量”西布曲明，但FDA实验室检测结果却显示，每单位剂量的Venom HYPERDRIVE 3.0含有显著量的西布曲明。

该产品通过经销商和零售店渠道在美国、加拿大、波兰、瑞典、匈牙利、南非、荷兰、澳大利亚、法国和英国销售。该产品为红色塑料瓶装，每瓶含有90粒胶囊，条形码为UPC# 094922534743。

消费者应立即停止服用该产品，一旦出现任何不良反应应立即就医。消费者可通过发email至联系生产厂家，以获得更多有关如何返还产品的指导和询问任何问题。

医护人员和消费者可将有关该药的严重不良反应事件或质量问题通过在线方式或普通信件、传真和电话方式上报至FDA的MedWatch不良事件报告系统，具体方法如下：

• 在线：登陆www.fda.gov/MedWatch/report.htm
• 信件：从网址www.fda.gov/MedWatch/getforms.htm下载已预付邮资的FDA 3500表，填写完毕后寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• 传真：（800）FDA-0178
• 电话：（800）FDA-1088

欲了解关于所有受质疑减肥产品的更新目录，请参阅下列网址：www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html 。

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