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

Starting date:

June 29, 2009

Posting date:

June 29, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000788

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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.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

• Slimbionic
• Xsvelten
• Herbal Xenicol
• 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.

What you should do

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.

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

Background

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.

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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709