Backgrounders
	What to look for: Ephedra/ephedrine
	Frequently Asked Questions

Information

January 2002

Ephedra/ephedrine - Frequently Asked Questions

1. What is Ephedra?
Ephedra refers to several related species of herbs that commonly grow in desert areas. It is best known as a botanical source of the alkaloids ephedrine, pseudoephedrine and others. Ephedra species also contain many other constituents. Ephedra sinica, whose Chinese name is Ma Huang, has been used in recent years in products marketed for weight loss, body building and increased energy.

2. What is ephedrine?
Ephedrine is a chemical derivative of the herb Ephedra sinica and several other species of Ephedra, and was first isolated and used pharmaceutically about 100 years ago. It stimulates the central nervous and the cardiovascular systems, and causes the lung bronchi to dilate. Products containing ephedrine may use the compound extracted from Ephedra or be produced synthetically.

3. What is the problem with Ephedra/ephedrine? Why is Health Canada requesting a recall?
Health Canada currently authorizes the sale of oral products containing recommended or low dosages of Ephedra/ephedrine for use for short periods of time as nasal decongestants. These products carry an 8 digit Drug Identification Number (DIN), which indicates they have been approved by Health Canada. There are also products that contain Ephedra for use as traditional medicines.

However, Health Canada is aware that many unapproved products are sold for a variety of uses including weight loss, increased energy, body-building and euphoria. These unapproved products are usually combination products containing Ephedra/ephedrine with stimulants such as caffeine.

A health advisory was issued by Health Canada in June of last year, advising Canadians not to use products containing Ephedra/ephedrine 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. Most such reactions involved the use or overuse of combination products, which combine Ephedra/ephedrine with caffeine or other substances that increase its action. Since the last advisory, a product that combined large doses of ephedrine with caffeine has been reported as a contributing factor in one death.

.At the time of the last advisory, Health Canada had initiated a thorough risk assessment, and concluded that the following Ephedra/ephedrine products pose a health risk, and should be removed from the market:

• Ephedra/ephedrine products having a dose unit of more than 8 mg ephedrine or with a label recommending more than 8 mg/dose or 32 mg/day;

• combination products containing Ephedra/ephedrine together with stimulants (e.g. caffeine or other ingredients that would enhance the activity of Ephedra/ephedrine);

• 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.

4. Are there groups that are particularly at high risk? What are the side effects?
Products containing ephedrine are contra-indicated in heart disease, hypertension, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma and pheochromocytoma. Ephedra/ephedrine aggravates these conditions and therefore should not be used except if recommended by and under the surveillance of a health care professional. It should also not be used during pregnancy and lactation.

Adverse effects of ephedrine can include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, gastrointestinal distress, irregular heartbeat, tachycardia, insomnia, flushing, sweating, hypertension, stroke, seizures, psychosis and death.

As well, due to the stimulant and euphoric properties of Ephedra/ephedrine, certain segments of the population are more likely to abuse these products, increasing the risk to their health.

5. How can a consumer identify these products?
Although there are potentially hundreds of these products on the shelves, which makes them difficult to identify by product name, consumers are advised to check the label. Things in particular to watch out for:

• Check for a Drug Identification Number. If the product is making a health claim, it should have one. DINs identify the product as having been approved by Health Canada. Ephedra/ephedrine products without DINs have not been assessed for safety by Health Canada, and as such their safety cannot be assured.

• Consumers are particularly advised to check the label for products that combine Ephedra/ephedrine with stimulants such as caffeine. A list of some of the herbs or plants that contain caffeine is being provided to consumers.

• Products that are marketed for appetite suppression, weight-loss, metabolic enhancement, increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects may contain Ephedra/ephedrine and should be treated with some suspicion. These products have not been assessed by Health Canada and have no assurance of content, safety or effectiveness.

• If you are taking a product that contains Ephedra/ephedrine, and are not sure whether the product meets the recommended standard of 8mg/a dose, 32 mg/day for ephedrine, consult your pharmacist.

6. Will all products labeled to contain Ephedra/ephedrine be taken off the shelves?
No. Commercial Ephedra/ephedrine products being sold as nasal decongestants and having a dose equal to or under the recommended dosage of 8mg/a dose or 32mg/day will continue to be available. Products containing Ephedra which are marketed for traditional use according to the combinations and dosages described in texts pertaining to traditional medicine, will also continue to be available, provided they do not contain caffeine and that the ephedrine content does not exceed the 8 mg/a dose to a maximum of 32 mg/day.

As well, the recall does not affect Ephedra/ephedrine products that are being dispensed by practitioners who are dispensing/compounding the drug for individual patients.

7. Why take action now?
Health Canada issued a public advisory regarding these products in 1997 and in June 2001 cautioning Canadians of the possible adverse health effects these unapproved products may pose. At the time of the last advisory (June 2001), Health Canada had initiated a risk assessment to determine the risk to health of these products. The assessment concluded these products pose a serious risk to health, and now Health Canada is removing them from the market.

8. What compliance activities are being done?
Health Canada has / will:

• issued a Public Advisory to inform Canadian consumers of the Class 1 risk to health posed by unapproved Ephedra/ephedrine products for some population groups with pre-existing conditions, such as hypertension, diabetes, heart disease, etc. A Class I risk to health is defined as a situation where there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death;

• issued a Customs Lookout for the products in question to ensure that they are stopped at the border and not imported into Canada;

• issued a Letter to Canadian manufacturers, distributors and importers to advise them of the recall, and request that they discontinue the sale of these products at all levels of the market, including retail;

• issued letters to manufacturers of Ephedra/ephedrine products that carry DINs and provide doses greater than 8 mg/dose or greater than 32 mg/day, requesting that they provide safety data to support these higher doses in their products;

• communicated its actions to other international regulatory agencies regarding these products as per information sharing agreements, and to other stakeholders as appropriate;

• follow-up with importers, manufacturers and retailers to assess the effectiveness of the recall for these products; and

• conduct a random market survey within 6 months of the recall to determine whether these products have found their way back onto the Canadian market. Non-compliant products will be removed from the shelves.

9. How did so many unapproved products get on the market?
Natural health products are currently regulated as either a food or a drug, and as such, have been dealt with on a case by case basis. New regulations are being proposed which will enable better regulation of natural health products such as these.

It should be noted that these products are often clandestinely imported into Canada. Health Canada initiated a risk assessment in June to determine the full scope of the risk posed by these products. To help mitigate risks to consumers in the meantime, Health Canada issued a public advisory warning consumers not to use these products, as a precautionary measure, while the risk assessment could be completed.

10. Since these products are so widespread, how can you be sure all products in question will be removed?
Health Canada has implemented the following actions to remove as many as possible:

• issued a letter to manufacturers, distributors and importers to inform them of the recall, requesting that they remove these products from sale.

• issued a letter to as many associations as possible including the Canadian Trucker's Association, the Canadian Consumers' Association, fitness centres, gyms, the College of Physicians and Surgeons, Canadian Association of Family Physicians, among others to inform them of the recall.

• issued an indefinite Customs Lookout for these products to ensure they do not enter into Canada.

This is also a matter of supply and demand, and consumers have a role to play in keeping these products off the shelves. Health Canada has in the past (in 1997 and in June of this year) issued two advisories, advising the public not to consume these products, but a continuing demand for these products has ensured they remain on the shelves. Canadians could also contribute to this initiative in ceasing to purchase such products and eliminate the demand.

Health Canada inspectors will undertake a random market survey in approximately 6 months following the recall of these products to determine how successful the recall was, and if further actions need to be taken.

11. If a consumer has concerns about a product they find on the shelf, who can they contact?
Consumers can direct their questions and complaints to the Health Products and Food Branch Inspectorate Operational Centre closest to them (please see list below).

Health Products and Food Branch Inspectorate Operational Centres