Health Canada

Health Canada

May 01, 2009 17:19 ET

Health Canada Reviewing Hydroxycut Products in Light of U.S. Advisory

OTTAWA, ONTARIO--(Marketwire - May 1, 2009) - Health Canada is aware of the public warning (http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html) issued by the U.S. Food and Drug Administration (FDA) Warning on May 1, 2009 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 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. Health Canada is reviewing the situation in Canada and has actively been working with the FDA regarding this matter.

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 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, and will provide Canadians with any new safety information when the review is completed.

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada Web site (www.healthcanada.gc.ca/medeffect)

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada Web site (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this Web site.

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709