FDA Survey Of ED Supplements Shows Contamination With Viagra, Levitra
This article was originally published in The Tan Sheet
Executive Summary
A "first-of-its-kind" FDA survey of 17 dietary supplements marketed to treat erectile dysfunction revealed that seven of the products are actually illegal drugs due to adulteration with active ingredients used in Rx ED treatments, the agency states in a July 12 release
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Joy of Love recall
Jen-on Herbal Science International announces April 17 a voluntary nationwide recall of Joy of Love supplement product sold in 12-capsule blister packs packaged in a retail box. The City of Industry, Calif.-based firm recalled the product, marketed as a dietary supplement, after FDA investigators found the product is made with an ingredient close in structure to erectile dysfunction drug, vardenafil (Schering and GlaxoSmithKline's Levitra). Vardenafil may present an additional risk if used in combination with medications such as nitrates, which are found in certain Rx drugs used to treat conditions such as high blood pressure or heart disease. FDA ramped up surveillance of supplements marketed to treat erectile dysfunction in 2006 when a survey of 17 products revealed seven of the products as illegal drugs due to adulteration with active ingredients used in Rx ED treatments (1"The Tan Sheet" July 17, 2006, p. 4)...
Liviro3 recall
Los Angeles-based Ebek says Jan. 19 it is issuing a voluntary nationwide recall of its supplement Liviro3 because the product contains tadalafil (Cialis), which is used to treat erectile dysfunction. Therefore, FDA says the product is an unapproved drug. FDA advised Ebek to recall the product because tadalafil may interact with nitrates found in prescription drugs and may lower blood pressure to dangerous levels. No illnesses have been reported to the company. In July 2006 an FDA survey found seven dietary supplements marketed to treat ED contained illegal drugs due to adulteration with active ingredients used in Rx ED treatments (1"The Tan Sheet," July 17, 2006, p. 4)...
Canada Libidus warning
Using the natural health product Libidus, which contains vardenafil, the same active ingredient contained in GlaxoSmithKiline's/Schering-Plough's Levitra, could pose health risks, especially for people with heart problems, taking heart medications or at risk for stroke, Health Canada announces. Libidus, which is manufactured in Malaysia by Bio-Gulf, contains a modified form of vardenafil, but the substance is not declared on product packages, the Canadian health agency says. Winnipeg, Manitoba-based distributor NorthRegentRX has been contacted and is recalling the product from Canadian markets, the agency says. Results of an FDA survey from earlier this year identified Libidus, and six other supplements as illegal because they contain undeclared non-dietary chemicals similar or equivalent to sildenafil or vardenafil (1"The Tan Sheet" July 17, 2006, p. 4). Products containing vardenafil should not be used by people taking nitrate medication because combining the products could result in dangerously low blood pressure...