Health Canada is warning consumers not to use Vigoureux, an unauthorized product promoted for the treatment of erectile dysfunction. The product may pose serious health risks, as it was found to contain the prescription drug sildenafil, which is not indicated on the label and 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 this product.
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 sildenafil may be associated with other side-effects including 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 type of nitrate drug (e.g., nitroglycerin) due to the risk of developing potentially life-threatening low blood pressure.
Vigoureux is labelled as distributed by International in Montreal, Quebec and labelled in French only. The product may be available at retail outlets across Canada. Health Canada advises retailers to remove Vigoureux from their shelves, and consumers should return the product to the place of purchase. Canadians who have used Vigoureux and are concerned about their health should consult with a health care professional.
Health Canada advises consumers not to use Vigoureux or any other unauthorized products promoted for the treatment of erectile dysfunction that are advertised as "all natural", as such products may contain undeclared pharmaceutical ingredients that may pose serious risks to health. Consumers who are concerned about erectile dysfunction should consult with their health care professional to discuss appropriate and authorized 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.
вторник, 30 ноября 2010 г.
четверг, 25 ноября 2010 г.
LEVITRA Successfully Treats Erectile Dysfunction In Men With Dyslipidemia
Results of the first prospective trial specifically designed to evaluate erectile function in erectile dysfunction (ED) patients with dyslipidemia show that LEVITRA (vardenafil HCl), used in treating ED, significantly improves the ability of men with ED and dyslipidemia to achieve and maintain an erection for successful sexual intercourse. These data were presented at the Sexual Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).
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