Update - Health Canada Reviewing Hydroxycut Products in light of U.S. Advisory

Information Update
2009-66
May 3, 2009
For immediate release

OTTAWA - Health Canada is updating Canadians about Hydroxycut products. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a public warning regarding certain Hydroxycut products. The FDA is advising U.S. consumers to stop using Hydroxycut products as there have been reports of liver injuries potentially associated with this product in the United States.

Hydroxycut products are natural health products (dietary supplements in the U.S.) promoted for weight-loss, fat burning, and energy-enhancement. No Hydroxycut products are currently authorized for sale in Canada.

The company Iovate Health Sciences Inc. is voluntarily recalling the following list of products in Canada:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Max Aqua Shed Capsules
• Hydroxycut 24 Caplets

There are three additional products that were mentioned in the FDA advisory that are not sold in Canada by Iovate:

• Hydroxycut Carb Control Caplets
• Hydroxycut Natural Caplets
• Hydroxycut Hardcore RTD (Ready to Drink)

Health Canada has received 17 domestic adverse reaction (AR) reports associated with Hydroxycut products in Canada. These adverse reactions relate to the cardiovascular, respiratory, gastrointestinal, and neurological systems. None of the adverse reactions reported in Canada relate to liver injury. Health Canada is reviewing the situation in Canada and is currently examining the product formulas, ingredients, dosages, or other causes which may pose a risk to health in relation to the use of Hydroxycut products.

Health Canada has actively been working with the FDA and the company regarding this matter. The Department will continue to monitor adverse reaction reports and the recall associated with Hydroxycut products, and will provide Canadians with any new safety information.

Health Canada advises consumers not to use any unauthorized health products, as they may pose a risk to health. Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.

Consumers who are concerned about symptoms possibly associated with the use of these products should consult with their health care practitioner.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this Web site.

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709