Health Canada, Jan 9, 2002
2002-01
January 9, 2002
Advisory
Health Canada requests
recall of certain products containing Ephedra/ephedrine
OTTAWA- Health Canada is requesting a recall from the
market of certain products containing Ephedra/ephedrine after
a risk assessment concluded that these products pose a serious risk
to health. Adverse events including stroke, heart attacks, heart
rate irregularities, seizures, psychoses and deaths have been
reported in association with the use of some products containing
Ephedra/ephedrine. Ephedra refers to several related species
of herbs. Ephedrine is one of many chemical derivatives of
this herb.
This voluntary recall deals with products that are marketed
without approval. These 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.
A full table of ingredients containing caffeine is attached to
this advisory;
-
Ephedra/ephedrine products with labelled or implied
claims for appetite suppression, weight loss promotion, metabolic
enhancement, increased exercise tolerance, body-building effects,
euphoria, increased energy or wakefulness, or other stimulant
effects.
Health Canada advises those Canadians who may be consuming these
products to stop using them, and return them to their points of
sale. Canadians suffering from heart conditions, high blood pressure
and diabetes are among those particularly at risk.
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.
If a consumer has concerns about a product with a Drug
Identification Number (DIN), and is not sure if the recommended
dosage exceeds the 32 mg ephedrine/day dose limit, they should
consult with their pharmacist. Consumers who identify remaining
products on the shelves can call their regional Health Canada
offices to report complaints. Their contact information is provided
as an attachment.
Health Canada is issuing letters to Canadian manufacturers,
distributors and importers requesting that they discontinue sale of
these products and that the products be recalled from all levels of
the market, including retail. A customs lookout has also been
issued, to ensure that these products are not imported into
Canada.
A health advisory was issued by Health Canada in June of last
year, advising Canadians not to use products containing the herb
Ephedra, in combination with caffeine and other stimulants,
for purposes of weight loss, body building or increased energy. At
the time of that advisory, 60 adverse events had been reported in
Canada related to the use of Ephedra/ephedrine. Since then, a
product which combined large doses of ephedrine with caffeine has
been reported as a contributing factor in one death in Canada.
Health Canada will be issuing a regulatory letter to
manufacturers of products which exceed this recommended dosage.
Products with DINs that are being sold as nasal decongestants and
have doses equal to or less than the upper limits of 8 mg
ephedrine/dose and 32 mg ephedrine/day will continue to be
available.
Health Canada will continue to monitor reports of adverse events
associated with Ephedra/ephedrine, and will take further action if
necessary. A random market survey will be undertaken within 6 months
of the requested recall to determine whether these products have
found their way back onto the Canadian market. Non-compliant
products will be removed from the shelves.
The text in this article was prepared by Health Canada.