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

Starting date:

September 15, 2010

Posting date:

September 15, 2010

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-110003752

• What you should do
• Who is affected
• What industry professionals should do
• Background
• Affected products
• Report health or safety concerns
• What Health Canada is doing
• Images

"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.

What you 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.

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 or fungal), certain eye disorders, and osteoporosis. Retailers who have this product in stock are also affected.

What industry professionals 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.

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."

Affected products

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance 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

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).

Images

Select thumbnail to enlarge - opens in a new window