Health Canada

Health Canada

September 15, 2010 09:00 ET

"Arth-Forth": Unauthorized Herbal Product May Pose Serious Health Risks

OTTAWA, ONTARIO--(Marketwire - Sept. 15, 2010) -

The issue:

"Arth-Forth", an unauthorized product promoted as an herbal supplement and distributed by Ka Wing Hong Ltd., was tested by Health Canada and found to contain a steroid prescription drug, dexamethasone, that was not declared on the product's labelling. Prescription drugs should only be taken under the supervision of a healthcare practitioner as they may cause serious side effects.

Who is affected: 

Consumers who may have bought or used "Arth-Forth," particularly people with gastrointestinal ulcers, Cushing's syndrome, severe heart problems, uncontrolled diabetes, uncontrolled high blood pressure, tuberculosis, severe systemic infections (viral, bacterial, fungal), certain eye disorders, and osteoporosis. Retailers who have this product in stock are also affected.

What consumers should do

  • Consult your healthcare practitioner before stopping use if you are presently taking this product or have been taking it on an ongoing basis. Suddenly stopping dexamethasone use may cause serious health effects. 
  • Read the label of the health products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM). Some natural health products may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is in the process of reviewing their application for licensing.
  • Report any adverse reactions potentially related to this product to Health Canada (see below).
  • Return any unused product to a pharmacy for safe disposal.

What retailers should do

  • Remove this product from stock and take to a pharmacy for safe disposal. You are also encouraged to report to Health Canada's Inspectorate if you have this product for sale by calling, toll free, 1-800-267-9675.  

What Health Canada is doing:

Samples of "Arth-Forth" obtained by Health Canada Inspectors at a Chinese health store in Vancouver, B.C. were tested and found to contain dexamethasone. While the store has voluntarily provided its stock of "Arth-Forth" to Health Canada, it's possible the product may be available for sale at other retail stores.

Health Canada has confirmed the product is distributed by Ka Wing Hong Ltd. The department has requested the company immediately stop sale and initiate a recall of the product. As well, Health Canada is working with the Canada Border Services Agency to stop shipments of "Arth-Forth" from entering Canada. Health Canada will continue to monitor the situation and should the product be found available for sale on the Canadian market, Health Canada will take appropriate action.

Consumers may submit complaints regarding the sale of unapproved health products, or regarding the safety, efficacy or quality of health products by calling Health Canada's Inspectorate, toll-free, at 1-800-267-9675. For more information, see the guidance document How to submit a consumer complaint (GUI-044) (http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui_44_consumer_consommateur_cp-pc-eng.php).

Background:

Health Canada testing of "Arth-Forth" found an average of 96.2 micrograms 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.

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects associated with 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.

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

Consumers are advised to consult with their healthcare practitioner before discontinuing this product as stopping dexamethasone may cause serious symptoms, 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.

Health Canada has not received any reports of adverse reactions associated with the use of "Arth-Forth." 

To see the product affected (Arth-Forth) please follow this link:
http://media3.marketwire.com/docs/Product%20affected.pdf

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

To report a suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Reporting Form and send it to us using one of these methods:

Fax: 1-866-678-6789
   
E-mail: CanadaVigilance@hc-sc.gc.ca
   
Internet: www.healthcanada.gc.ca/medeffect
   
Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

Related Health Canada Web content:

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories ( http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/ ).

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Egalement disponible en français

Contact Information

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