Counterfeit Cialis Seized in the Greater Toronto Area

This is a reprint of the Health Canada alert.

Following an R.C.M.P. seizure of counterfeit Cialis in the Greater Toronto Area, Health Canada is reminding Canadians that unauthorized and counterfeit health products can pose serious risks to their health as they have not been reviewed by the Department for safety, quality, or efficacy.

The seized counterfeit Cialis actually contains sildenafil, a prescription medication, whereas the market authorized version of Cialis contains the prescription medication tadalafil. Sildenafil may pose serious health risks, particularly to people with heart problems. In order to minimize health risks, Canadians should not take any prescription drug that has not been prescribed to them by a health care practitioner.

Who is affected:

Canadians who have purchased or used the counterfeit Cialis product.

What consumers should do

• Consult your healthcare practitioner with any questions or concerns regarding use of this counterfeit product.
• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN–HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.
• Report any adverse reaction potentially related to this counterfeit product to Health Canada (see below).
• Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about counterfeit drugs.
• Contact Eli Lilly Customer Response Centre at 1-888-545-5972 for information regarding Cialis.

What Health Canada is doing:

Health Canada has been working with the R.C.M.P., has been in contact with Eli Lilly the manufacturer of the market authorized Cialis, and will take compliance action as appropriate.

Background:

Counterfeit health products may be mistaken as other health products that Health Canada has authorized for sale. Counterfeit products may contain medicinal and other ingredients not listed on the label, dangerous additives and/or microbial contaminants. In addition they may lack the labelled active ingredients. Or they may contain the type of medication which requires that the patient be supervised by a healthcare practitioner. For all of these reasons, counterfeit drugs could cause serious health problems.

For more information regarding Health Canada’s approach to counterfeit health products please consult Health Canada’s Policy on Counterfeit Health Products POL -0048

Sildenafil should only be used under the supervision of a health care practitioner. Products authorized for sale containing sildenafil indicate that it should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems may be at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Consumers can differentiate between the counterfeit Cialis and the market authorized product by examining the packaging of the blister packs (see photos below). All market authorized Cialis blister packs have a coloured oval on the front of the blister pack that changes colour from copper to green  when the package is raised up and down in front of you, the counterfeit blister packs do not have this feature. The counterfeit blister packs also have a lot number of 05668 and have the active ingredient listed as “Tadalafil” in four (4) different languages.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-009.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

To report a suspected adverse reaction to these or other health products, please contact Heath Canada’s Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9