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Unauthorized Health Product, Herbal Diet Natural, May Pose Serious Health Risks
- Starting date:
- March 25, 2010
- Posting date:
- March 25, 2010
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Unauthorized products, Product Safety, Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-110004182
Health Canada is warning Canadians that an unauthorized health product, Herbal Diet Natural, has been found on the Canadian market and contains an undeclared pharmaceutical ingredient similar to the prescription drug sibutramine. Sibutramine may pose serious health risks, particularly to people with heart problems. Consumers who have purchased Herbal Diet Natural are advised to consult with a medical professional if they have used the product or have concerns about their health.
Sibutramine is a prescription drug used to treat obesity. The use of sibutramine may cause serious side effects, including cardiovascular reactions, such as increased blood pressure, chest pain, and stroke, in addition to dry mouth, difficulty sleeping and constipation. Sibutramine should be used only under the supervision of a healthcare practitioner. Sibutramine should not be taken by people who have had a heart attack, coronary artery disease, heart-related chest pain, irregular heart beats, congestive heart failure, a stroke or symptoms of a stroke, in individuals with unstable or poorly controlled high blood pressure, or in patients who have clinically diagnosed depression or have a psychiatric illness. Sibutramine is not recommended for women who are pregnant, breastfeeding or planning to become pregnant.
According to the product label, Herbal Diet Natural also contains glucomannan used for the treatment of weight loss. In January 2010, Health Canada advised Canadians that natural health products containing the ingredient glucomannan in tablet, capsule or powder form, which are currently on the Canadian market, have a potential for harm if taken without at least 8 ounces of water or other fluid. The risk to Canadians includes choking and/or blockage of the throat, esophagus or intestine. These products should not be taken immediately before going to bed.
Health Canada is working with the Canada Border Services Agency to stop future importation of any shipments of Herbal Diet Natural from entering Canada. Health Canada is also advising consumers to return the product to the place of purchase.
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.
To date, no adverse reactions from the use of this product have been reported in Canada.
Report health or safety concerns
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 website.
Related AWRs
Dangerous and unauthorized weight loss products continue to be sold across Canada
2012-07-25 | Health products
Media enquiries
Health Canada
613-957-2983
Public enquiries
613-957-2991
1-866-225-0709
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