Health Canada advises consumers
not to use weight loss products containing ephedrine
and caffeine.
May 24, 2006
Health Canada is advising
consumers not to use any combination of ephedrine
and caffeine because of the risk of serious and
possibly fatal effects.
Two particular products pose potential
health risks, WestPharm Hydro-Lean capsules, and
a combination of 4Ever Fit ephedrine and caffeine
pills.
Canadians suffering from heart conditions,
high blood pressure and diabetes are among those
particularly at risk.
WestPharm Hydro-Lean has not been
assessed by Health Canada for safety, effectiveness
or quality and is not authorized for sale in Canada.
It is, however, distributed through the Internet
and may have been brought into Canada either by
personal importation or other means. Health Canada
is working with the Canada Border Services Agency
to prohibit further importation of this product.
The 4Ever Fit ephedrine and caffeine
pills are packaged in separate bottles, but are
sold together in a Convenience Pack. Ephedrine
and caffeine are authorized in Canada as separate
products, but they are not authorized to be sold
or taken in combination. 4Ever Fit Convenience
Pack has been recalled from retail stores by the
Canadian distributor, 4Ever Fit, due to the risk
of serious and potentially fatal effects.
When used in combination with caffeine
and other stimulants, ephedrine has caused reported
adverse events ranging from dizziness, tremors,
headaches and irregularities in heart rate to
seizures, psychosis, heart attacks and stroke.
One report of an adverse reaction suspected to
be related to the use of Hydro-Lean has been reported
to Health Canada. The symptoms in this case included
an elevated heart rate and general discomfort.
All individuals who have used WestPharm
Hydro-Lean or the ephedrine and caffeine tablets
in the 4Ever Fit Convenience Pack, or any other
products containing ephedrine and stimulants such
as caffeine, should stop consuming them. Such
products should not be used for weight loss, increased
energy, body building or any other purpose.
Consumers who believe they have
experienced adverse effects from taking these
products should consult their health care practitioner.
Both ephedra and ephedrine are authorized
by Health Canada for use only as a nasal decongestant
in over-the-counter cold products. All such authorized
products carry an eight-digit Drug Identification
Number (DIN) or Natural Product Number (NPN) on
the label and should be used only as directed,
for short periods of time. Currently, the maximum
allowable dosage for ephedrine is 8 mg in a single
dose or 32 mg per day. The maximum allowable dosage
for ephedra is 400 mg in a single dose or 1,600
mg per day.
Consumers should avoid using unauthorized
products that contain ephedra or ephedrine in
combination with caffeine or other stimulants
because of the health risk. As a source of ephedrine,
the label on these products may list: ma huang,
Chinese ephedra, ma huang extract, ephedra, Ephedra
Sinica, ephedra extract, ephedra herb powder,
Sida Cordifolia or epitonin. As a source of caffeine
or other stimulants, the label on these products
may list: green tea, guarana, yerba mate, cola
nut and yohimbine.
To obtain further information about
ephedra/ephedrine, please consult the following
document on the Health Canada website: Ephedra/ephedrine
- Frequently Asked Questions
Health Canada stresses that ordering
health products online without professional medical
advice and monitoring can pose a number of health
risks. Before taking any health products, consumers
are urged to discuss the issue with their health
care practitioner.
To report finding WestPharm Hydro-Lean,
the Combination Pack of 4Ever Fit ephedrine and
caffeine pills, or any other unauthorized products
combining ephedrine and a stimulant, such as caffeine,
on the Canadian market, please contact the Health
Products and Food Branch Inspectorate at: 1- 800-267-9675.
To report a suspected adverse reaction
to WestPharm Hydro-Lean, the 4Ever Fit Combination
Pack of ephedrine and caffeine tablets or any
other health product, please contact the Canadian
Adverse Drug Reaction Monitoring Program (CADRMP)
of Health Canada by one of the following methods.
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture,
AL 0701C
Ottawa, ON
K1A 0K9
Email: cadrmp@hc-sc.gc.ca
Public inquiries about issues raised
in this advisory should be directed to Health
Canada at (613) 957-2991, or toll free at 1-866-225-0709.
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