Health Canada, May 23, 2006
2006-33
May 23, 2006
Advisory
For immediate release
Health Canada advises consumers not to use weight loss products containing ephedrine and caffeine.
OTTAWA - 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.
The text in this article was prepared by Health Canada.