Fortodol

Foreign Product Alert
2009-84
June 03, 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

Date of alert: June 03, 2009

Source of Alert:

• U.K. Food Standards Agency
• U.K. Medicines and Healthcare products Regulatory Agency
• Swedish Medical Products Agency
• Norwegian Medical Products Agency
• Food Safety Authority of Ireland

Product Names:

• Fortodol, which is also sold under the names:
  • Donsbach Miradin
  • Lepicol Miradin
  • Leppin Miradin, and
  • Miradin

Manufacturer / Place of Origin:
Manufactured by Donsbach, California, U.S.A.

• Distributed in Sweden by Hela Pharma
• Distributed in the U.K. by Lepicol Ltd
• Distributed in Northern Ireland by Natural Health Products

Product Description
Fortodol, which is also sold under the product names listed above, is promoted as an herbal, turmeric-based dietary supplement used to relieve pain and inflammation.

Reason for Warning
Several foreign regulatory agencies (listed above) have warned consumers not to buy or use Fortodol (also sold under other product names, listed above) after it was found to contain the pharmaceutical ingredient nimesulide.

Nimesulide is a drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. It is not authorized in Canada because of its association with liver damage.

Possible Side-Effects
In addition to the risk of liver damage, side-effects associated with nimesulide include gastrointestinal bleeding, anemia, kidney failure and reduced blood clotting ability.

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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.