Archive – Health Canada Advises Consumers Not to Use Weight Loss Products Containing Ephedrine and Caffeine

Starting date:

May 23, 2006

Posting date:

May 23, 2006

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Unauthorized products

Audience:

General Public

Identification number:

RA-110001218

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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.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709