November 26, 2008
For immediate release
OTTAWA - Health Canada is warning consumers not to use Firm Dose and Granite Rooster, two products promoted to enhance male sexual performance, as these products may pose serious health risks. Firm Dose was found to contain an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil, while the product Granite Rooster was found to contain an undeclared pharmaceutical ingredient similar to the prescription drug tadalafil. These drugs should only be used under the supervision of a health care professional. Patients with pre-existing medical conditions, including those with heart problems, those taking heart medications, or those at risk for strokes, may be at an increased risk of serious health effects associated with the use of these products.
Use of known prescription drugs for erectile dysfunction such as sildenafil or tadalafil 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, other possible associated side-effects can include vision loss, seizure, sudden decrease or loss of hearing, dizziness, prolonged erection, headache, flushing, nasal congestion, indigestion and abdominal pain. Sildenafil and tadalafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerin) due to the risk of developing potentially life-threatening low blood pressure.
Firm Dose and Granite Rooster capsules are individually packaged and the labels are depicted in the pictures shown below.
Firm Dose
Health Canada advises consumers not to use Firm Dose, Granite Rooster or any other unauthorized products promoted for the treatment of erectile dysfunction that are advertised as "all natural", as such products may contain undeclared prescription ingredients that may pose serious risks to health. Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label. Consumers who are concerned about erectile dysfunction should consult with their health care professional to discuss appropriate and authorized treatments.
Health Canada advises retailers to remove Firm Dose and Granite Rooster from their shelves, and consumers should return the product to the place of purchase. Health Canada is taking steps to confirm that the product has been removed from the Canadian market. Canadians who have used Firm Dose or Granite Rooster and are concerned about their health should consult with a health care professional.
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 report 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
Canada 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 area of the Health Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
