Que She

Starting date:

July 29, 2010

Posting date:

July 29, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-120001264

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

Source of Alert

U.S. Food and Drug Administration

Manufacturer / Place of Origin

Unknown

Product Description

Que She is promoted as an herbal weight loss supplement. It is advertised as a "Slimming Factor Capsule" and as an "all-natural blend of Chinese herbs."

Reason for Warning

The U.S. FDA warned consumers not to buy or use Que She after it was found to contain undeclared fenfluramine, propranolol, sibutramine and ephedrine.

According to the U.S. FDA alert, the product has been widely distributed on the Internet, such as through the "Bouncing Bear Botanicals" website, as well as through the U.S. retail outlet "Sacred Journey" in Lawrence, Kansas.

Fenfluramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with primary pulmonary hypertension (severe lung disease) and heart valve disease.

Propranolol is a prescription drug used to treat cardiovascular conditions such as high blood pressure. It should only be taken under the supervision of a health care practitioner.

Sibutramine is a prescription drug used to treat obesity. It should only be taken under the supervision of a health care practitioner.

Ephedrine is authorized for the relief of nasal congestion. It is not authorized for sale in Canada as a stimulant or weight loss product.

Possible Side-Effects

Additional side-effects associated with fenfluramine include headache, drowsiness, dizziness, palpitation, diarrhea and dry mouth.

Side-effects associated with propranolol include decreased blood pressure, cold extremities (hands and feet), dizziness, fatigue, sexual dysfunction and difficulty breathing. Patients with cardiovascular conditions should consult their health care practitioner before stopping Que She as abrupt discontinuation of propranolol may cause serious side effects.

Side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Side-effects associated with ephedrine include fast or abnormal heartbeat, chest pain, high blood pressure, dizziness, headache, agitation, seizures, insomnia, and facial flushing.

What you should do

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.

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

Background

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.

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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Media Enquiries

Health Canada
(613) 957-2983

Public Enquiries

613-957-2991
1-866-225-0709