Health Canada

 Health Canada,   Jun 9, 2003

2003-43
June 9, 2003

OTTAWA - Health Canada is reminding the public about the serious health risks of taking Ephedra / ephedrine products for reasons other than nasal decongestion.

In January 2002, Health Canada issued a Health Advisory for Canadians not to use certain products containing Ephedra / ephedrine - especially those containing caffeine and other stimulants with labelled or implied claims such as weight loss, body-building or increased energy. Those products were also recalled by Health Canada at the time. The recall pertained to products with caffeine / stimulants or were over the maximum allowable dosage. Currently, the maximum allowable dosages for Ephedra / ephedrine in products is 8 mg ephedrine/single dose or 32mg ephedrine/day. Products containing Ephedra which are marketed for traditional medicine will continue to be available, provided they do not contain caffeine and that the ephedrine content does not exceed 8 mg/dose to a maximum of 32 mg/day (400 mg/dose or 1600 mg/day for Ephedra).

Health Canada requested this recall from the Canadian market after its risk assessment concluded that these products pose a serious risk to health. Over 60 adverse events including strokes, heart attacks, heart rate irregularities, seizures, psychoses and deaths have been reported in Canada in association with the use of products containing Ephedra / ephedrine.

Products affected by the January 2002 recall include:

• Ephedra / ephedrine products having a dose unit of more than 8 mg of ephedrine or with a label recommending more than 8 mg/dose or 32 mg/day and/or are labelled or implied for use exceeding seven days;
• All combination products containing Ephedra / ephedrine together with stimulants (e.g. caffeine) and other ingredients which might increase the effect of Ephedra / ephedrine in the body;
• Ephedra / ephedrine products with implied and unproven claims for appetite suppression, weight loss promotion, metabolic enhancement, increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects.

Although Health Canada has monitored the removal of over 250 000 products containing Ephedra / ephedrine from the market to date, it is following up on complaints that some products subject to recall continue to be to sold to Canadian consumers. These illegal products are being sold under the counter, in back rooms and at gyms. This activity contravenes the Food and Drugs Act and Regulations and places the health and potentially even the life of consumers in danger.

Health Canada has also learned that some retail employees have been selling consumers legally available Ephedra / ephedrine products (eg. for nasal decongestion and not exceeding maximum allowable doses), and advising consumers of ways to obtain the same effect as those products subject to the Health Canada recall. This activity is also illegal and places the health and potentially the lives of consumers in danger.

These illegal practices present challenges to the full enforcement of the Ephedra / ephedrine recall. Along with the release of this advisory, Health Canada is also considering other enforcement actions to address the illegal sale of Ephedra / ephedrine products.

Health Canada is requesting that consumers and retailers help Health Canada take responsibility for reducing the supply and demand of these products subject to the recall in an effort to prevent additional deaths and serious adverse health events in Canada. The removal of the remaining high-risk products from the market requires a co-operative approach among consumers, retailers, distributors, importers, manufacturers and Health Canada. Health Canada asks that consumers report retail outlets that carry these products or are involved in illegal activities relating to these products, by calling the Health Products and Food Branch Inspectorate toll-free telephone line at 1-800-267-9675.

Health Canada warns Canadians to be vigilant with the Ephedra / ephedrine products they consume. If consumers are unsure of the status and or legality of the product they have purchased, they should speak with their pharmacist, their physician or Health Canada at the above toll-free telephone number. Health Canada reminds consumers to check for Drug Identification Number (DIN) and to read the label of every product they use.

The text in this article was prepared by Health Canada.