Health Canada

Health Canada

July 10, 2009 16:46 ET

Health Canada Warns Consumers Not to Use the Product Specific Formula Arthro-Ace

OTTAWA, ONTARIO--(Marketwire - July 10, 2009) -

Note to Editors: A photo for this release will be available on Marketwire's website.

Health Canada is warning consumers not to use the unauthorized health product labelled as Specific-Formula Arthro-Ace as it was found to contain undeclared dexamethasone and may cause serious health effects. Specific Formula Arthro-Ace is being promoted as a natural health product for the relief of arthritic pain.

While Canadians already using this product are advised to discontinue use, they should consult with their physician prior to doing so. Abrupt discontinuation of dexamethasone may cause symptoms of withdrawal, such as loss of appetite, nausea, vomiting, drowsiness, fatigue, confusion, headache, fever, joint and muscle pain, low blood pressure, low blood sugar, dizziness and fainting.

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Prescription drugs should only be taken under the supervision of a health care practitioner as they have the potential to cause serious side-effects.

Side effects associated with the use of dexamethasone include irregular heartbeat, increased blood pressure, stomach ulcers, blood disorders, skin, muscle and bone damage, nervous system disorders, infections, increased blood sugar, eye disorders, and mood disorders.

Testing of product samples by Health Canada found an average of 0.23 mg of dexamethasone per pill. According to product labelling, three pills are to be taken twice daily over 15 days. This amount could be sufficient to cause serious adverse health effects in patients using this product.

As well, dexamethasone should not be taken by people who have certain conditions including gastrointestinal ulcers, Cushings syndrome, severe heart problems, uncontrolled diabetes, uncontrolled high blood pressure, tuberculosis, severe systemic infections (viral, bacterial, fungal), certain eye disorders, and osteoporosis.

Specific Formula Arthro-Ace products are not authorized for sale in Canada. However, they can be found in retail stores such as Chinese health stores and are sold online. Health Canada advises retailers to remove Specific Formula Arthro-Ace from their shelves and consumers to return the product to the point of purchase. Health Canada warns Canadians not to purchase these products from the Internet or from any other source. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.

Health Canada advises consumers not to use any unauthorized health products, as they may pose a risk to health. Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.

Health Canada has received one adverse reaction report involving Specific Formula Arthro-Ace. The report involved a consumer who experienced irregular heart beat and tremors after taking the product.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada Web site (www.healthcanada.gc.ca/medeffect)

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada Web site (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this website.

A photo for this release will be available on Marketwire's website at the following address: http://www.marketwire.com/library/20090710-health_800.jpg.

Egalement disponible en francais.

Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709