Warning
2006-10
February 22, 2006
For immediate release
OTTAWA - Health Canada is warning consumers not to use two unapproved products being marketed as natural health products for weight loss because they may contain substances that could lead to serious side effects or injury.
Recently, the U.S. Food and Drug Administration found that Emagrece Sim, also known as the Brazilian Diet Pill, and Herbathin, contain the prescription-only pharmaceutical compound fluoxetine HCl (the active ingredient in Prozac), the controlled substance chlordiazepoxide HCl (an active ingredient in Librax) and the controlled substance fenproporex. Emagrece Sim and Herbathin are not authorized for sale in Canada.
Consumers who are taking these products are advised to continue taking them and consult with their physicians immediately, as medical supervision is required for discontinuing chlordiazepoxide HCl, fluoxetine HCl, and fenproporex. Abrupt withdrawal of these drugs could lead to serious physical and psychological symptoms, such as fatigue, agitation, accelerated heart beat, anxiety, depression or suicidal thoughts.
Consumers who are taking these products are also urged to be cautious since their mental alertness and physical co-ordination may be impaired. Their ability to perform certain tasks such as driving or operating machinery could be affected. Since Emagrece Sim and Herbathin contain active drug ingredients, both products could cause serious interactions with other drugs or natural health products.
Emagrece Sim and Herbathin are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim. Although these products are not authorized for sale, they have been imported and distributed in the U.S. by Emagrece Sim Laboratories Inc. and Herbathin Inc. (doing business as EMIEX Corp.). Should Heath Canada become aware of these products being sold in Canada, appropriate action will be taken to ensure their removal from the market.
Consumers should exercise caution when purchasing products from outside Canada or from the Internet as those products may not have undergone the same degree of assessment as those authorized for sale in Canada.
Canadians are encouraged to maintain a healthy weight by following the recommendations of Canada's Food Guide to Healthy Eating coupled with appropriate physical activity, as diet products that provide results in the short term could have undesirable or harmful effects.
Health Canada advises consumers to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Emagrece Sim or Herbathin in Canada. Health Canada has notified the Canada Border Services Agency to detain any shipment of these products at the border.
To date, no adverse reactions from the use of Emagrece Sim and Herbathin have been reported in Canada. To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Email: cadrmp@hc-sc.gc.ca
Public inquiries about issues raised in this advisory should be directed to Health Canada at either (613) 957-2991 or 866 225-0709.
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Media Enquiries:
Jirina Vlk
Health Canada
(613) 957-2988
Public Enquiries:
(613) 957-2991
1-866 225-0709
