Slimbionic, Xsvelten, Herbal Xenicol, BioEmagrecim (FDA update)

Foreign Product Alert
2009-107
June 29, 2009
For immediate release

Health Canada is advising consumers not to use the following products specified below due to concerns about possible side-effects. More info

Source of Alert: U.S. Food and Drug Administration (FDA)
Product Names:

1. Slimbionic
2. Xsvelten
3. Herbal Xenicol
4. BioEmagrecim (FDA update)

Manufacturer / Place of Origin: Unknown

Product Description
Slimbionic, Xsvelten, Herbal Xenicol, and BioEmagrecim are promoted as "natural" or "herbal" dietary supplements used for weight loss.

Reason for Warning
The FDA recently expanded a warning to consumers not to buy or use 68 weight loss products to include three additional products, Slimbionic, Xsvelten and Herbal Xenicol. Slimbionic and Xsvelten were found to contain the undeclared pharmaceutical ingredient sibutramine, while Herbal Xenicol was found to contain undeclared cetilistat.

The FDA's expanded warning also provided updated information on the product BioEmagrecim. In its earlier communication, the FDA warned that this product contained sibutramine. The FDA has since found that BioEmagrecim also contains the undeclared pharmaceutical ingredients fluoxetine, furosemide and fenproporex.

Cetilistat is an experimental weight loss drug that is not authorised for sale in Canada. It is similar to Xenical, which is a prescription weight loss drug and should only be taken under the supervision of a health care practitioner.

Sibutramine is used to treat obesity while fluoxetine is used to treat depression and furosemide is a diuretic (water pill) used to remove excess fluid from the body. All three are prescription drugs and should only be taken under the supervision of a health care practitioner.

Fenproporex (also known as perphoxene) is an amphetamine-like (stimulant) drug that is not authorized in Canada.

The FDA has initiated product recalls in the U.S. and may take additional enforcement measures if necessary.

Health Canada issued a previous Foreign Product Alert for the 68 weight loss products.

Possible Side-Effects
Side effects associated with xenical include abdominal discomfort, anal leakage, increased stool volume and frequency, and fatty/oily stool.

Side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Side effects associated with fluoxetine include headache, insomnia, drowsiness, anxiety, nausea, diarrhea, dry mouth, loss of appetite and excessive sweating.

Side effects associated with furosemide include muscle cramps, dizziness, low blood pressure, headaches and nausea.

Side effects associated with amphetamines include fast or abnormal heart beat, chest pain, high blood pressure, dizziness, headache, agitation, seizures, insomnia, facial flushing, sweating and indigestion.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.