Advisory - Thirteen unauthorized products seized at various Ontario retailers may pose serious health risks

OTTAWA, March 23, 2016 /CNW/ -

The issue

Health Canada seized thirteen unauthorized drugs promoted for sexual enhancement or as bodybuilding supplements from four separate retailers in Ontario (see table below). The products were found to contain or were labelled to contain various prescription drug substances and other drug substances that may pose serious risks to the health of Canadians.

What you should do

• Consult with your health care professional if you have used any of these products and have health concerns.
• Read the product label. Health products that have been authorized for sale by Health Canada have an eight-digit DIN, a DIN-HM or a NPN.
• Verify that your health products have been authorized for sale by searching the Drug Product Database, Medical Devices Active Licence Listing (MDALL) and the Licensed Natural Health Product Database.
• Report any adverse events to Health Canada
• Report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.

Who is affected

Consumers who have purchased or used any of these products, particularly those with heart conditions.

Background

Sildenafil and tadalafil are prescription drug ingredients. Products containing these ingredients should only be used under the supervision of a health care practitioner. Sildenafil and tadalafil should not 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 are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Desmethyl carbondenafil is a substance similar to sildenafil and may pose similar health risks

Dapoxetine is a drug ingredient. Side effects include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.

Yohimbine is a prescription drug ingredient. Products containing yohimbine should only be used under the supervision of a health care practitioner. The use of drugs containing yohimbine (either as yohimbine hydrochloride or yohimbe bark extract) may result in serious adverse reactions, particularly in people with high blood pressure, or heart, kidney or liver disease. Side effects associated with yohimbine include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, pregnant women or nursing women.

Report health or safety concerns

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

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

What Health Canada is doing

Health Canada has seized the products from the retail locations. Should additional retailers or distributors of these products be identified, Health Canada will take appropriate action and inform Canadians.

SOURCE Health Canada

PDF available at: http://stream1.newswire.ca/media/2016/03/23/20160323_C2277_PDF_EN_649791.pdf

Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709