OTTAWA, ONTARIO -- 11/25/09 --
Health Canada is warning consumers not to use Herblex "Once More", an unauthorized product promoted to enhance male sexual performance, as this product may pose serious health risks. Herblex "Once More" was found to contain sildenafil, a prescription medication not indicated on the label. Sildenafil may cause serious side effects in some individuals and should only be used under the supervision of a health care practitioner.
The product was also found to be contaminated with high levels of mould and bacteria.
A picture of the product is available at this address: http://media3.marketwire.com/docs/HC_Herblex_Once_More.jpg
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. The excessive numbers of aerobic bacteria and moulds could also contribute to the health risks, especially for people with compromised immune systems.
Use of known prescription drugs for erectile dysfunction such as 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, other possible 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 should not be used by individuals taking any nitrate drug (e.g. Nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.
Herblex "Once More" is labeled as distributed by Herblex Canada, Surrey, British Columbia. Canadians who have used "Once More" and are concerned about their health should consult a health care practitioner. Health Canada has received no reports of adverse reactions.
Health Canada advises consumers not to use Herblex "Once More" or any other unauthorized products promoted for the treatment of erectile dysfunction, as such products may pose serious risks to health. Consumers who are concerned about erectile dysfunction should consult their health care practitioner to discuss appropriate treatments.
Drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.
Consumers requiring more information about this warning 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect(TM) Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canadawebsite
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and either:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect(TM) Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canada website. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this section.
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
