Warning
2005-124November 17, 2005For immediate release
Chinese Translation
OTTAWA - Canada is warning consumers not to take the Chinese medicine Shortclean because it contains glibenclamide (glyburide) and phenformin, two prescription drugs that could pose a serious health risk for people with low blood sugar or diabetes. Shortclean has been promoted for the control of diabetes and as being derived from only natural ingredients.
Shortclean is not approved for sale in Canada and does not appear to be available to Canadians via the Internet. However, Canadians travelling overseas may have purchased this product for personal use and imported it into Canada. The Department of Health in Hong Kong recently recalled Shortclean and advised the public against its use.
Glyburide is a prescription drug, authorized for sale in Canada, that is used to lower blood sugar. It is safe and effective when used as labelled in approved medications and under medical supervision. People who have low blood sugar or those with diabetes can inadvertently receive significantly high amounts of glyburide by consuming Shortclean. Similarly, Shortclean when used with other diabetes drugs could increase the effects of those drugs, leading to a dangerous drop in blood sugar.
Phenformin, the second drug ingredient found in Shortclean, was once used in the treatment of Type 2 diabetes. Phenformin was removed from the Canadian market in 1977, and is banned in several countries, including Hong Kong, Singapore, Germany, France and the United States. The bans resulted from numerous international reports of life-threatening lactic acidosis, an often fatal metabolic disorder in which an abnormal amount of lactic acid accumulates in the blood.
People with diabetes who use Shortclean as their only treatment will not be able to effectively monitor the undeclared and uncontrolled amounts of glyburide and phenformin. This could result in serious health risks that may lead to a life-threatening situation.
Further, the label displayed on the product is advertised only in Chinese. Pertinent information about dosage and side effects therefore may not be available to the consumer.
Consumers should immediately stop using Shortclean and seek medical attention, especially if they are currently being treated with diabetes drugs. Immediate medical attention should also be sought if consumers are experiencing symptoms of low or high blood sugar that include: rapid heartbeat, fatigue, blurred vision, headache, excessive hunger, excessive thirst, profuse sweating or confusion, numbness of the extremities, tingling of the mouth, difficulty breathing, seizures or loss of consciousness.
Canadians should only use drugs and natural health products that have been authorized for sale by Health Canada. Authorized drugs and natural health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM). This authorization indicates that the products have been assessed by Health Canada for safety, efficacy and quality.
The public is encouraged to inform Health Canada if they are aware of the sale of Shortclean by calling the Health Products and Food Branch Inspectorate at 1-800-267-9675.
To date, no adverse reactions from the use of Shortclean have been reported in Canada or internationally. To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca
Website:
http://www.hc-sc.gc.ca/dhp-mps/advers_react_neg/index_e.html
-30-
Media Inquiries:
Nathalie Lalonde
Health Canada
(613) 957-1803
Public Inquiries:
(613) 957-2991
1-866 225-0709
