Health Canada is advising consumers not to use the unauthorized natural health products Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra because they are adulterated with pharmaceutical ingredients that should only be used under medical supervision. The use of these products could pose a serious health risk, especially for patients with existing medical conditions such as heart problems, those who are taking heart medications, or those who may be at risk for strokes.
Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra are promoted for the treatment of erectile dysfunction. These products are or may have been sold over the internet or brought into Canada by travellers for personal use. However, these products are not authorized for sale in Canada.
Zimaxx is adulterated with sildenafil, which is the active pharmaceutical ingredient found in the prescription drug Viagra. Actra-Rx, 4Everon and Nasutra are adulterated with modified forms of sildenafil. Vigor-25 is adulterated with a modified form of vardenafil, which is the active pharmaceutical ingredient found in the prescription drug Levitra.
The use of Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra could cause serious side-effects including sudden vision loss, increased heart rate, decreased blood pressure, penile tissue damage, permanent loss of potency, and urinary tract infections. Other less serious side-effects may include indigestion, headaches, flushing and dizziness.
The use of these products can also produce a specific type of vision loss called nonarteritic anterior ischemic optic neuropathy in people over the age of 50 years, and in those with risk factors such as high blood pressure, high cholesterol, diabetes, smoking, or those with a blood vessel problem in the eye that can lead to stroke. This condition can be irreversible.
Products containing sildenafil or vardenafil should not be used by individuals who are taking any nitrate medications because combining these products could result in the development of potentially life-threatening low blood pressure.
A previous Health Canada warning was issued for Nasutra in May 2006 because this product was found to contain sildenafil. Nasutra has since been found to contain a modified form of sildenafil, and is therefore included in this advisory.
Consumers who are using any of these five products should stop taking them and consult with a health professional if they have concerns about their health. Consumers are advised to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find any of these products in Canada. Health Canada has notified the Canada Border Services Agency to detain any shipment of these products at the border.
Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To date, no adverse reactions suspected to be associated with the use of these five products have been reported to Health Canada. To report a suspected adverse reaction to this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa, Ontario K1A 0K9