Energy II, Apisate, Obat Asam Urat and Asam Urat

Foreign Product Alert
2008-141
August 22, 2008
For immediate release

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

Date of alert: August 22, 2008
Source of Alert: Hong Kong Department of Health
Product Names: Energy II, Apisate, Obat Asam Urat and Asam Urat
Manufacturer / Place of Origin: The manufacturer and place of origin for the above four products is unknown.

Product Description
Energy ll and Apisate are promoted for weight loss.

Obat Asam Urat and Asam Urat are marketed for the treatment of gout (arthritis).

Energy II:

Apisate:

Obat Asam Urat and Asam Urat:

Reason for Warning
The Hong Kong Department of Health has warned against the use of the above four products because they were found to contain undeclared pharmaceutical ingredients.

Energy ll contained sibutramine and Apisate contained fenfluramine. Obat Asam Urat and Asam Urat both contained dexamethasone, piroxicam and phenylbutazone.

Sibutramine is a prescription drug used in the treatment of obesity and should only be used under the guidance of a health professional. Fenfluramine, also used in the treatment of obesity, is currently prohibited for sale in Canada because of its association with heart valve disease.

Dexamethasone and piroxicam are prescription anti-inflammatory drugs and should only be used under the supervision of a health professional. In Canada, the anti-inflammatory phenylbutazone is no longer manufactured for human use because of severe side-effects such as bone marrow suppression.

Possible Side-Effects
Unsupervised use of sibutramine may cause headaches, increased heart rate and blood pressure, chest pain and stroke.

Fenfluramine is currently prohibited for sale in Canada because of its association with heart valve disease.

Phenylbutazone use has been associated with gastrointestinal bleeding and bone marrow suppression, and is no longer manufactured for human use.

Unsupervised use of dexamethasone may cause irregular heartbeat, increased blood pressure, increased cholesterol, increased blood sugar, menstrual irregularities, suppression of growth in children, fluid and electrolyte disturbances, peptic ulcer, blood disorders, allergic skin reaction, muscle and bone damage, seizures, and mental and mood disorders. Dexamethasone should be avoided by patients with kidney problems, fungal infections or other systemic infections.

Piroxicam is associated with serious side-effects such as peptic ulcers and bleeding in the digestive system. It should be avoided by patients with active peptic ulcers and liver disease. Patients taking products containing acetylsalicylic acid (Aspirin) or other non-steroidal anti-inflammatory drugs should also avoid piroxicam because it may increase the risk of gastrointestinal bleeding and ulcers.

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Media Inquiries:
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 any of 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.