Foreign Product Alert
2007-132
September 28, 2007
For immediate release
Health Canada is advising consumers not to use the following product listed in the table below due to concerns about possible side-effects. More info
Asam Urat Flu Tulang, PJ Dewandaru
| Date of alert |
September 28, 2007 |
| Source of Alert |
Health Sciences Authority of Singapore |
| Product Name |
Asam Urat Flu Tulang, PJ Dewandaru |
| Manufacturer / Place of Origin |
PJ Dewandaru / Jateng, Indonesia |
| Products Description |
Asam Urat Flu Tulang, PJ Dewandaru is a health product promoted to treat joint pain, rheumatism and arthritis.
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| Reason for Warning |
The Health Sciences Authority of Singapore advised the public not to use the health product Asam Urat Flu Tulang, PJ Dewandaru because if it was foundto contain the undeclared drugs dexamethasone, diclofenac and acetaminophen.
Dexamethasone is a prescription anti-inflammatory and immunosuppressant drug.
Diclofenac is a non-steroidal anti-inflammatory prescription drug used to treat pain and fever.
Acetaminophen is an over-the-counter drug used for the relief of fever and mild to moderate pain.
Dexamethasone, diclofenac and acetaminophen have the potential to cause serious side-effects. Dexamethasone and diclofenac are prescription drugs and should only be taken under the supervision of a health care professional. |
| Possible Side Effects |
Use of dexamethasone may result in several side-effects, including 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 damage, seizures, and hallucinations.
Use of diclofenac may cause gastrointestinal problems (ulceration and bleeding), dizziness, liver problems and anemia.
Long-term use of high doses of acetaminophen may cause serious liver damage. |
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Media Inquiries:
Alastair Sinclair
Health Canada
(613) 957-1803
This product is not authorized for sale in Canada and has not been found in the Canadian marketplace. However, it is possible this product could be purchased by Canadians travelling abroad or has been brought into Canada through personal importation 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 product listed in the table 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.
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