ST LOUIS (MD Consult) - On May 1, 2009 the US Food and Drug Administration (FDA) issued a warning advising consumers to immediately stop using Hydroxycut products manufactured by Iovate Health Sciences Inc, of Oakville, Ontario. Some Hydroxycut products have been associated with serious liver injuries. Iovate has agreed to a market recall of Hydroxycut products.

Hydroxycut products are dietary supplements that are marketed for weight and water loss, and as fat burners, energy enhancers, and low-carborhydrate diet aids. They have been sold under the Iovate and MuscleTech brand names.

The FDA has received 23 reports of serious health problems in association with Hydroxycut use, ranging from jaundice and liver enzyme elevation to liver damage requiring liver transplantation. Liver injury, though rare, was reported by patients who were taking Hydroxycut doses according to label recommendations. One death attributed to liver failure was received. The injuries reported to the FDA occurred in persons aged 21 to 51 years. No other cause for liver disease was identified in these patients. In the majority of cases, no preexisting medical condition that would predispose the consumer to liver injury was identified. In some cases, discontinuation of Hydroxycut usage resulted in recovery of liver function.

Other health problems reported with the use of Hydroxycut products include seizures, cardiovascular disorders, and rhabdomyolysis. The FDA, which continues its investigation, has not yet determined which Hydroxycut ingredients, dosages, or other health-related factors may be associated with the risks described.

The list of products being recalled by Iovate currently includes the following:

• Hydroxycut Regular Rapid Release Caplets;
• Hydroxycut Caffeine-Free Rapid Release Caplets;
• Hydroxycut Hardcore Liquid Caplets;
• Hydroxycut Max Liquid Caplets;
• Hydroxycut Regular Drink Packets;
• Hydroxycut Caffeine-Free Drink Packets;
• Hydroxycut Hardcore Drink Packets (Ignition Stix);
• Hydroxycut Max Drink Packets;
• Hydroxycut Liquid Shots;
• Hydroxycut Hardcore RTDs (Ready-to-Drink);
• Hydroxycut Max Aqua Shed;
• Hydroxycut 24;
• Hydroxycut Carb Control; and
• Hydroxycut Natural.

Health care professionals and consumers are encouraged to report serious adverse events or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, Md 20852-9787, or by fax to 1-800-FDA-0178. The FDA is urging healthcare professionals to review any cases of hepatitis occuring in their patients to try and determine if any may be related to the use of dietary supplements.

 

圣路易斯(MD Consult)——美国食品和药物管理局(FDA)在2009年5月1日发出警告，呼吁消费者立即停止服用Hydroxycut系列产品，这些产品由加拿大安大略省奥克维尔的Iovate Health Sciences制造，部分Hydroxycut产品被指与严重肝损伤发生相关。Iovate公司已同意从市场召回该系列产品。

 

在售的Hydroxycut系列产品是一种减肥膳食补充剂，可以减轻体重、消除水肿，还可以作为燃烧脂肪、增强能量和低碳减肥法的辅助品。已经以“Iovate”和“MuscleTech”2个品牌面市。

 

美国FDA已接到23宗与Hydroxycut相关的严重健康问题的报告，轻者发生黄疸和肝脏酶谱升高，重者发生肝损害并需要肝移植。尽管服用该产品导致肝脏受损的个案极为少见，但报告出现这种情况的患者所服用的剂量都是遵照药品说明书上的推荐用量。据FDA报道，发生肝损害者年龄在21～51岁，其中1人因肝衰竭导致死亡。可以确定的是，这些患者均未罹患其他原因致肝损伤的疾病，大多数患者也不存在明确的易罹患肝损伤的医学问题。而 且，一些患者在停止使用Hydroxycut产品后肝功能得到恢复。

 

使用Hydroxycut产品报告的其他健康问题包括癫痫、心血管疾病和横纹肌溶解症。美国FDA称将继续展开调查，但至今尚未确定Hydroxycut的何种成分、剂量或其他健康有关因素可能与描述的风险相关。

 

目前正由Iovate召回的产品清单如下：

 

• Hydroxycut普通速释囊片(Hydroxycut Regular Rapid Release Caplets)；

• Hydroxycut脱咖啡因速释囊片(Hydroxycut Caffeine-Free Rapid Release Caplets)；

• Hydroxycut硬核溶液囊片(Hydroxycut Hardcore Liquid Caplets)；

• Hydroxycut Max溶液囊片(Hydroxycut Max Liquid Caplets)；

• Hydroxycut普通饮品(Hydroxycut Regular Drink Packets)；

• Hydroxycut脱咖啡因饮品(Hydroxycut Caffeine-Free Drink Packets)；

• Hydroxycut硬核饮品(Hydroxycut Hardcore Drink Packets; Ignition Stix)；

• Hydroxycut Max饮品(Hydroxycut Max Drink Packets)；

• Hydroxycut液体喷丸(Hydroxycut Liquid Shots)；

• Hydroxycut硬核即饮品(Hydroxycut Hardcore RTDs);

• Hydroxycut Max Aqua Shed；

• Hydroxycut 24；

• Hydroxycut低碳(Hydroxycut Carb Control)；

• Hydroxycut自然(Hydroxycut Natural)。

 

鼓励医疗卫生专家和消费者向美国FDA MedWatch项目组举报在使用这些产品的过程中出现的严重不良事件或产品质量问题，举报热线1-800-FDA-1088，传真1-800-FDA-0178或寄信至以下地址：5600 Fishers Lane, Rockville, MD 20852-9787。FDA敦促医护专业人员对任何发生在本机构的肝炎患者进行回顾研究，确定其发生是否与使用膳食补充剂有关。