Archived – Lu Quan

Starting date:

November 10, 2008

Posting date:

November 10, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000592

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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.

Source of alert

Hong Kong Department of Health

Product name

Lu Quan

Manufacturer / Place of origin

Unknown

Product description

Lu Quan capsules

Reason for warning

The Hong Kong Department of Health (HKDH) warned consumers not to buy or use Lu Quan because it was found to contain the undeclared pharmaceutical ingredients glibenclamide and sildenafil:

• Glibenclamide (also known as glyburide) is used in the treatment of diabetes while sildenafil is used in the treatment of erectile dysfunction.
• Glibenclamide and sildenafil are both prescription drugs and should only be used under the supervision of a health care practitioner.

Possible side effects

Glibenclamide is a prescription drug used for the management of high blood sugar in certain diabetic patients:

• Unsupervised use of glibenclamide may cause severe lowering of blood sugar which can be characterized by flushing, paleness, chills, trembling, headache, dizziness and confusion.
• Other side effects such as nausea, vomiting, heart burn, and abdominal pain may also occur.
• Glibenclamide is not recommended for use in patients with unstable diabetes and/or those on insulin, or for patients with severe liver, thyroid or kidney problems.

Unsupervised use of sildenafil by patients with heart disease can result in:

• Serious cardiovascular side effects such as sudden cardiac death, heart attack, stroke, hypertension, chest pain and abnormal heartbeat.
• Additionally, use of sildenafil may be associated with other side-effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain.
• Products containing sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.

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

Images

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