2008-41
March 11, 2008
For immediate release
OTTAWA - Health Canada is reminding consumers not to use products containing Ephedra or ephedrine, either alone or in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy. Use of products containing Ephedra or ephedrine in combination with caffeine and other stimulants may have serious, possibly fatal, adverse effects Health Canada is advising consumers that these products are not authorized for use.
Ephedra is a botanical source of the active ingredient ephedrine. Adverse effects associated with ephedrine can include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, gastrointestinal distress, irregular or fast heartbeat, insomnia, flushing, sweating, hypertension, stroke, seizures, psychosis and death.
Health Canada has previously warned consumers against the use of unauthorized Ephedra/ephedrine-containing products in Canada, in 2005 and 2006, due to the risk of serious adverse effects.
Use of products containing ephedrine is not recommended in people with heart problems, hypertension, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma (serious eye disorder) and pheochromocytoma (serious gland disorder) because Ephedra/ephedrine aggravates these conditions. Consumers should use Ephedra/ephedrine products only for the approved indication of nasal decongestion, and should not exceed the maximum allowable dosage described in the Ephedra and ephedrine/pseudoephedrine labelling standards, unless this has been recommended by and you are under the surveillance of a health care practitioner. These products should also be avoided during pregnancy and lactation.
Ingredient labels on these products may list Ma Huang, Chinese Ephedra, Ma Huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia or epitonin, all of which indicate a source of ephedrine. Sources of caffeine in these products may include: green tea, guarana, yerba mate, cola nut and yohimbe, while other stimulants may include bitter orange, or its active ingredient, synephrine. Labelling standards for Ephedra and Ephedring/pseudoephedrine are on the Health Canada web site.
Health Canada is also reminding Canadian retailers not to sell unauthorized products containing Ephedra or ephedrine.
Consumers who have seen these products for sale in Canada should contact Health Canada's Health Products and Food Branch Inspectorate at 1-800-267-9675.
Consumers are reminded to exercise caution if they choose to purchase Ephedra/ephedrine-containing products or health products over the internet. International reports of serious adverse reactions have been associated with unauthorized products containing Ephedra/ephedrine in combination with other stimulants that were purchased online.
Health Canada advises all individuals who may have used Ephedra/ephedrine-containing products alone or in combination with other stimulants for weight loss, body building or increased energy to stop consuming them and consult their health care practitioner if they have experienced any adverse effects from taking the product.
To report a suspected adverse reaction to one of these products please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
