Archived - Zhong Hua Niu Bian

Starting date:

June 24, 2008

Posting date:

June 24, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-12000760

• 
  Images

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

Singapore's Health Sciences Authority

Product names

Zhong Hua Niu Bian

Manufacturer / Place of origin

Unknown

Product description

Zhong Hua Niu Bian is an herbal/proprietary Chinese medicine product promoted for treatment of erectile dysfunction.

Reason for warning

Singapore's Health Sciences Authority has warned against the use of Zhong Hua Niu Bian because it has been found to contain sildenafil, tadalafil, glibenclamide and sibutramine.

Sildenafil and tadalafil are prescription drugs authorized for treatment of erectile dysfunction. Glibenclamide is a prescription drug used in the treatment of diabetes. Sibutramine is a prescription drug used for treating obesity. All four of these medications should only be used under the supervision of a health care professional.

Possible side effects

Unsupervised use of sildenafil or tadalafil by patients with pre-existing heart disease can result in serious cardiovascular side effects such as sudden cardiac death, heart attack, chest pain, abnormal heartbeat, hypertension or hypotension, and stroke. Additionally, use of sildenafil or tadalafil may be associated with other side effects including vision loss, seizure, prolonged erection, headache, flushing, nasal congestion, and abdominal pain.

Sildenafil or tadalafil 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. Glibenclamide (also known as glyburide) is authorized for the management of high blood sugar in certain diabetic patients. Severe low blood sugar is a side effect that can present as flushing, paleness, chills, trembling, headache, dizziness and confusion. Other side effects such as nausea, vomiting, heartburn, and abdominal pain may occur. Glibenclamide is not recommended for patients with unstable diabetes and/or those on insulin, or patients with severe liver, thyroid or kidney problems.

Use of sibutramine may cause headaches, increased heart rate and blood pressure, chest pain, and stroke.

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

Select thumbnail to enlarge - opens in a new window