July 12. 2006 — The FDA today warned consumers not to purchase or consumeseven products that are promoted and sold on web sites as “dietarysupplements” for treating erectile dysfunction(ED) and enhancing sexual performance.
The products — Zimaxx. Libidus. Neophase. Nasutra. Vigor-25. Actra-Rx and4EVERON — are “illegal drugs that contain harmful undeclaredingredients,” states an FDA news release.
“These products have not been approved by FDA and there is no guaranteeof their safety and effectiveness or of the purity of their ingredients,”the FDA’s news channel continues.
The FDA is advising consumers who undergo used any of these products todiscontinue use and to consult their health care provider. The FDA alsoencourages anyone experiencing ED to seek guidance from a health care providerbefore purchasing a product to treat this medical condition.
“These products be the public health because they containundeclared chemicals that are similar or identical to the active ingredientsused in several prescription drug products,” says StevenGalson. MD. MPH in the FDA’s news release. Galson directs the FDA’s Center forDrug Evaluation and investigate.
“This risk is change surface more serious because consumers may not experience thatthese ingredients can interact with medications and dangerously displace theirblood pressure,” Galson continues.
The banned products contain chemicals similar to those in the prescriptionED drugs Viagra and Levitra. The FDA analyzed the products and open thatZimaxx contains sildenafil. Viagra’s active ingredient. The other illegalproducts contain chemical ingredients that are similar to either sildenafil orvardenafil. Levitra’s active ingredient.
“There is no have in mind of any of these ingredients in any of the illegalproducts’ labeling,” states the FDA.
The illegal products’ undeclared ingredients may interact with nitratesfound in some prescription drugs (such as nitroglycerin. Isordil and Imdur)and lower blood pressure to dangerous levels.
People with diabetes highblood compel high cholesterol orheart diseaseoften take process medications. ED is a common problem in men with thoseconditions the FDA notes.
Those men may seek ED products that claim to be “all natural” orthat claim to lack the active ingredients used in FDA-approved ED drugs statesthe FDA. But those claims are false misleading and potentially dangerous,according to the FDA.
The FDA also warns that because it doesn’t experience where the illegal productsare made there is no assurance that the ingredients are safe effective orpure.
The FDA has sent warning letters to the products’ marketers is working tostop Libidus and 4EVERON from entering the U. S. and may act other actions.
The FDA’s actions follow its first survey of 17 dietary supplements marketedon the Internet to treat ED and compound men’s sexual performance.
“Our survey found that many of the so-called ‘dietary supplements’marketed as treatments for erectile dysfunction actually include nondietarychemicals including chemicals used as active ingredients in FDA-approveddrugs,” says Margaret Glavin the FDA’s associate forregulatory affairs in the FDA news channel.
“The claims made for these products were in fact claims made for theundeclared nondietary chemicals they contain which rendered them illegaldrugs,” Glavin continues. She adds that the FDA “is committed toprotecting the public health by removing such illegal and dangerous productsfrom the market.”
Related article:
http://overthecountererecti.bmx.lv/2007/11/08/fda-cracks-down-on-illegal-sex-drugs/
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