Warning
2008-124
August 06, 2008
For immediate release
OTTAWA - Health Canada is warning consumers not to use Rize 2 The Occasion capsules (Rize2 2), an unauthorized product promoted for the treatment of erectile dysfunction, because it may pose serious health risks. Rize 2 contains an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil which should only be use d under the supervision of a health care professional. The product may pose serious health risks, especially for patients with pre-existing medical conditions such as heart problems, those who may be taking heart medications, or those who may be at risk f or strokes.
Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. Additionally, use of s ildenafil may be associated with other side-effects including vision loss, seizures, sudden decrease or loss of hearing, dizziness, prolonged erections, headaches, flushing, nasal congestion, indigestion and abdominal pain. Sildenafil should not be used b y individuals taking any type of nitrate drug (e.g., nitroglycerin) due to the risk of developing potentially life-threatening low blood pressure.
The distributor, Cana International Distributing, is conducting a voluntary recall of all lot s of Rize 2 that are available at retail outlets across Canada and over the Internet. Health Canada advises retailers to remove this product from their shelves, and consumers should return the product to the place of purchase. Canadians who have used Rize 2 and are concerned about their health should consult with a health care professional. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.
In addition to Rize 2, Health Canada advises consum ers not to use any unauthorized erectile dysfunction products, and recommends that consumers talk to a health care professional about authorized treatments for erectile dysfunction.
Health Canada is also reminding consumers to be cautious r egarding the purchase of health products over the Internet or from outside of Canada, as these products may not have been assessed to the same standards as products approved for sale on the Canadian market.
Authorized health products will b ear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM). This authorization indicates that the produc ts have been assessed by Health Canada for safety, effectiveness and quality.
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. To r eport a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Cana da Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect Canada area of the Health Canada Web site.
