Archived – Junyu Jiaonanyihao

Starting date:

September 17, 2007

Posting date:

September 17, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Unauthorized products, Product Safety

Audience:

General Public

Identification number:

RA-12000186

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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

Hong Kong Department of Health

Product name

Junyu Jiaonanyihao

Manufacturer / Place of origin

Unknown Manufacturer / Unknown Origin.

Product description

Specific indications for the product are unknown.

Reason for warning

The Hong Kong Department of Health found Junyu Jiaonanyihao to contain the undeclared prescription drugs sibutramine and dexamethasone, as well as phenolphthalein, which is currently prohibited in Canada.

Sibutramine is a prescription drug used for treating obesity. Dexamethasone is a synthetic corticosteroid used in a variety of disorders associated with inflammation. These drugs should only be taken under the supervision of a health care professional.

Phenolphthalein was previously used in over-the-counter laxative preparations but is currently prohibited in Canada, as it may cause cancer. Individuals who may have been exposed to phenolphthalein should consult with their health care practitioner.

Possible side effects

Use of sibutramine may cause headaches, increased heart rate and blood pressure, chest pain and stroke.

Dexamethasone should not be used by individuals with an allergy to corticosteroids, with a systemic fungal infections, or if using a live virus vaccine, such as smallpox. Use of dexamethasone may be associated with certain side effects, such as increases in blood pressure, nervousness, sleep disturbances, infection, and vision changes.

Abuse of phenolphthalein-containing laxatives has been associated with stomach and intestinal bleeding, anemia, acute pancreatitis, and multiple organ damage in cases of massive overdose, including liver failure.

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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