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Canadians Advised Not to Use Stiff Nights or Any Unauthorized Product Promoted for Erectile Dysfunction
- Starting date:
- January 8, 2010
- Posting date:
- January 8, 2010
- Type of communication:
- Natural health products
- Source of recall:
- Health Canada
- Important Safety Information, Unauthorized products
- General Public
- Identification number:
Health Canada is advising consumers not to use the unauthorized product Stiff Nights after the U.S. Food and Drug Administration (FDA) found that this product contains an undeclared substance similar to the prescription drug sildenafil and may pose serious health risks, particularly to people with heart problems. Stiff Nights is promoted as an "all natural dietary supplement" used for male sexual enhancement. Health Canada has confirmed that Stiff Nights is being distributed in Canada as well.
The U.S. FDA issued a warning on the product after determining that it contains sulfoaildenafil, an unauthorized substance similar to sildenafil. According to the FDA warning, Stiff Nights is distributed in the U.S. and on the Internet by Impulsaria LLC of Grand Rapids, Michigan, and comes packaged in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.
Health Canada has contacted the known Canadian distributors and is taking steps to confirm that the product has been removed from the Canadian market. Health Canada is advising retailers to remove this product from their shelves, and consumers should return the product to the place of purchase. Consumers who have purchased Stiff Nights are advised not to use the product and to consult with a medical professional if they have used the product and have concerns about their health.
Sildenafil is used to treat erectile dysfunction and should only be used under the supervision of a health care practitioner. 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 are 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.
Health Canada reminds Canadians not to use any unauthorized products promoted for the treatment of erectile dysfunction and to use caution if considering buying health products or medications over the Internet.
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 and have been licensed for sale.
Health Canada has not received any reports of adverse reactions in Canada associated with the use of this product.
People concerned about erectile dysfunction should talk to their health care practitioner about appropriate treatments. Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at the MedEffect™ Canada section of the Health Canada website
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and either:
- Fax toll-free to 1-866-678-6789
Canada Vigilance Program
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.
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- Date modified: