Foreign Product Alert 2008-106 July 7, 2008 For immediate release
Health Canada is advising consumers not to use the following product listed in the table below due to concerns about possible side-effects. More info
Date of alert: July 07, 2008 Source of Alert: U.S. Food and Drug Administration Product Names: - Super Shangai Strong Testis Shangai Ultra Shangai Ultra X Lady Shangai Shangai Regular (also known as Shangai Chaojimengnan) Actra-Sx An unknown product containing the plant Lycium barbarum L. Adam Free NaturalUp Erextra Yilishen Blue Steel Hero Naturalë Super Plus
Manufacturer / Place of Origin: Products' trade names: Super Shangai; Strong Testis; Shangai Ultra; Shangai Ultra X; Lady Shangai; and Shangai Regular (also known as Shangai Chaojimengnan) Distributor: Shangai Distributor, Inc. / Coamo, Puerto Rico
Products' trade names: Blue Steel and Hero Distributor: Active Nutraceuticals or the Marion Group / Carrollton, GA, USA
Products' trade names: Actra-Sx; an unknown product containing the plant Lycium barbarum L.; Adam Free; NaturalUp, Erextra; Naturalë Super Plus; and Yilishen Distributor: unknown
Product Description These products are marketed as treatments for erectile dysfunction and/or sexual enhancement.
Reason for Warning The U.S. Food and Drug Administration issued a news release warning consumers not to use the products listed above, because they were all found to contain sildenafil or an unapproved substance with a structure similar to sildenafil.
Sildenafil is a prescription drug used for the treatment of erectile dysfunction, and should only be taken under the guidance of a health professional.
Possible Side-Effects Unsupervised use of sildenafil and substances with structures similar to sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, hypertension, chest pain and abnormal heartbeat.
Use of sildenafil may be also associated with other side-effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain. Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.
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Media Inquiries: Health Canada (613) 957-2983
For more details on these Foreign Product Alerts, please visit the Health Canada Web site.
These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.
Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.
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.
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed in the table in the Canadian marketplace.
For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.
As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada. |