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Foreign product alert

Archived - Tian Li

Starting date:
April 29, 2008
Posting date:
April 29, 2008
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-12000711

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

United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)

Product names

Tian Li

Manufacturer / Place of origin

unknown

Product description

Tian Li is marketed as a sexual enhancement product. (Photo not available)

Reason for warning

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) advised the public not to use the product Tian Li, because it was found to contain tadalafil and hydroxyhomosildenafil.

Hydroxyhomosildenafil is a compound similar in structure to sildenafil, though its safety and efficacy have not been reviewed. Tadalafil and sildenafil are prescription medications indicated for the treatment of erectile dysfunction that should only be taken under the guidance of a healthcare professional.

Possible side effects

Unsupervised use of tadalafil or 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 tadalafil or sildenafil may be associated with other side-effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain. Tadalafil and 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