Archived - Tian Sheng Yi Bao

Starting date:

April 30, 2008

Posting date:

April 30, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-12000732

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 names

Tian Sheng Yi Bao

Manufacturer / Place of origin

Unknown manufacturer / China

Product description

Tian Sheng Yi Bao is marketed as a proprietary Chinese medicine (photo not available).

Reason for warning

The Hong Kong Department of Health advised the public not to use the product Tian Sheng Yi Bao because it was found to contain two pharmaceutical products, glibenclamide and phenformin, which are not meant for self-care and could be associated with serious side-effects.

Glibenclamide is used in the treatment of diabetes and should only be used under the supervision of a health care professional. Phenformin is an unauthorized drug that was banned in Canada in 1977 due to its association with fatal lactic acidosis.

Possible side effects

Glibenclamide (trade name Glyburide) is a prescription medication authorized for the management of high blood sugar in certain diabetic patients. Severe low blood sugar is a side-effect that can present as flushing, paleness, chills, trembling, headache, dizziness and confusion. Other side-effects such as nausea, vomiting, heartburn, and abdominal pain may occur. Glibenclamide is not recommended for patients with unstable diabetes and/or those taking insulin, or for patients with severe liver, thyroid or kidney problems.

Phenformin was previously authorized for use in Canada as a prescription medication for the treatment of Type 2 diabetes. However, phenformin was removed from the Canadian market in 1977 due to international reports of life-threatening lactic acidosis. Phenformin has also been banned in several other countries, including Hong Kong, Singapore, Germany, France, and the U.S.

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