Health Canada Warns Consumers Not to Use the Product Specific Formula Arthro-Ace
OTTAWA, ONTARIO, Jul 10 (MARKET WIRE) --
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(TM) 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-en
.php)
from the MedEffect(TM) 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.
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
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