Therma Power (red and blue varieties), Grenade Fat Burner

Foreign Product Alert
2008-120
July 24, 2008
For immediate release

Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info

Date of alert: July 24, 2008
Source of Alert: U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
Product Names: Therma Power (red and blue varieties), Grenade Fat Burner

Manufacturer / Place of Origin
Therma Power: FMGH INC./ Mahe, Seychelles
Grenade Fat Burner: Unknown / United Kingdom

Product Description
Therma Power and Grenade Fat Burner are promoted for weight loss.

Therma Power comes in two varieties: Therma Power "red,"which contains Ephedra, and Therma Power "blue," which is Ephedra-free.

Therma Power "red" (with Ephedra):

Therma Power "blue" (without Ephedra):

Grenade Fat Burner is sold in 100-tablet containers:

Reason for Warning
The MHRA warned consumers not to use the ephedrine-containing products Therma Power (red variety) and Grenade Fat Burner after the products were associated with serious adverse reactions, including a report of death.

The MHRA also warned consumers about the ephedrine-free (blue) variety of Therma Power, because it contains synephrine and caffeine, a combination that has been associated with cardiovascular adverse reactions.

Use of products containing Ephedra or ephedrine in combination with caffeine and other stimulants may cause serious, possibly fatal, adverse effects. Health Canada has previously warned consumers against the use of unauthorized Ephedra/ephedrine-containing products, in 2005, 2006 and 2008, due to the risk of serious adverse effects.

Synephrine is a substance similar to ephedrine and may have similar cardiovascular adverse effects that could lead to stroke, heart attack and/or death. Caffeine is a stimulant that can significantly increase the effects of synephrine.

Possible Side-Effects
Ephedra is a plant source of the active ingredient ephedrine. Side-effects associated with the use of ephedrine include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, digestive problems, irregular or fast heartbeat, insomnia, flushing, sweating, high blood pressure, stroke, seizures, psychosis and death.

Use of products containing Ephedra/ephedrine or synephrine is not recommended for people with heart problems, high blood pressure, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma (serious eye disorder) and pheochromocytoma (serious gland disorder).

Consumers should use Ephedra/ephedrine products only for nasal decongestion, and should not exceed the maximum allowable dosage described in the Ephedra and ephedrine labelling standards, unless recommended and supervised by a health care practitioner. Labelling standards for Ephedra and ephedrine are on the Health Canada web site. These products should be avoided during pregnancy and lactation.

Weight-loss products containing synephrine are not authorized for sale in Canada.

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Media Inquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find any of the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.