JianBu HuQian Wan

Starting date:

May 10, 2011

Posting date:

May 10, 2011

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-120001684

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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.

Source of alert

Singapore Health Sciences Authority (HSA)

Product names

JianBu HuQian Wan

Manufacturer / Place of origin

According to the product label, the product is manufactured by Wan Shou Tang Medical Co Ltd, Beijing and distributed by Guo Guang Medical Sdn. Bhd.

Product description

According to the product label, JianBu HuQian Wan is promoted to treat joint pain, muscle aches and weak limbs. According to the label, it is used to treat "irritability due to the arthralgia, myasthenia of the limbs, lumbago, ache of the spinal column."

The product comes packaged in a yellow and green outer box containing a white bottle with red and white capsules. According to the HSA news release, the product's label carries an invalid Malaysian Product Registration Number "MAL05121196T," and inaccurate information regarding its manufacturer and distributor.

Reason for warning

The HSA warned consumers not to buy or use JianBu HuQian Wan after it was found to contain undeclared dexamethasone and chlorpheniramine.

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. It should be taken only under the supervision of health care practitioner. Chlorpheniramine is an over-the-counter antihistamine drug.

The HSA tested the product after receiving an adverse reaction report involving a 70-year-old female who had purchased the product outside of Singapore.

The HSA's investigation revealed that the Singapore woman had poor diabetic control with increased glucose levels as a result of taking the product. The patient was also reported to have developed varicose vein with blood clots, rapid weight gain and increased appetite after starting the product. These symptoms are similar to the adverse effects caused by the prolonged use of dexamethasone. The patient has since stopped consuming the product and is recovering from the adverse effects.

Possible side effects

Side effects associated with dexamethasone include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders.

Side effects associated with chlorpheniramine include drowsiness, dizziness, confusion and blurred vision.

What you should do

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.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

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.

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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

Images

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