FDA Declares Vigor-25 Unsafe

In recent years, the FDA has come across a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients which have nothing to do with dietary supplements. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain a contaminant. The FDA has urged consumers who have experienced negative side effects to stay away from such sexual enhancement products and seek help from a health care professional.

 

One such product, Vigor-25, marketed as a natural dietary supplement to enhance male sexual performance, has been banned by the FDA. Vigor-25, distributed by Piston Corp., is an OTC (over the counter) drug and is also sold on Internet sites. The product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient. The Office of Compliance in the FDA’s Center for Drug Evaluation and Research found a hidden ingredient, sildenafil, in this product, which is also the active ingredient in the prescription drug, Viagra.

 

Sildenafil could interact with prescription drugs known as nitrates, including nitroglycerin, often taken by men with diabetes, hypertension, hypercholesterolemia, and coronary heart diseases. This interaction can prove fatal as it causes a serious drop in blood pressure levels.  Such tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions. The reported death of a 26-year old man, possibly associated with the use of Vigor-25 is being investigated by FDA.

True Man, Energy Max, and Encore are the latest additions to a long list of dietary supplements that the FDA has warned consumers against. In July 2006, the agency analyzed 17 products marketed online to treat erectile dysfunction and found that many of them contained non-dietary chemicals, including active ingredients used in FDA-approved drugs. Supplements banned by FDA include: Zimaxx, Libidus, Neophase, Nasutra, Actra-Rx, and 4EVERON. More recently, FDA issued another warning on a product called Zencore, from Bodee LLC Inc (Century City, CA).

 

 

The FDA has urged health care professionals and consumers to report adverse events or side effects from use of Vigor-25 to:

 

Call: 800-332-1088 , 800-551-3989 

Fax: 800-FDA-0178

 

 

Spiked pills have turned up in Thailand, Taiwan, Canada, Australia, New Zealand, Hong Kong, Malaysia, the United Kingdom and the United States, according to Pfizer Inc., the developer of Viagra. The company said that 69 percent of the 3,400 supplements it purchased in China contained Sildenafil citrate. Under U.S. law, these pills are dietary supplements. Hence they are far less regulated than pharmaceuticals and face no market barriers. Viagra, by contrast, underwent years of testing before it was publicly available. While herbal alternatives often contain exact copies of the patented drugs, some makers tweak the molecules to retain the effect of the original pharmaceutical to avoid scrutiny by FDA and other testing labs.

 

Source:    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234408.htm