June 11, 2008, Miami – An illegally marketed “all-natural” dietary supplement for sexual enhancement and erectile dysfunction (ED) treatment has been recalled by the FDA due to a risky ingredient.

Certain samples of Xiadafil VIP Tabs have been found by FDA lab tests to contain the active ingredient hydroxyhomosildenafil, which is similar to Viagra’s sildenafil.

According to the FDA, hydroxyhomosildenafil may interact with nitrates found in some prescription drugs like nitroglycerin, which can lower blood pressure to life-threatening levels. For this reason, FDA did not approve the use of Xiadafil VIP Tabs as a treatment for erectile dysfunction, nor did it receive approval as a treatment for any other condition.

The FDA has ordered SEI Pharmaceuticals of Miami to recall all Xiadafil VIP Tabs sold in eight-tablet bottles (Lot # 6K029) or two-tablet blister cards (Lot # 6K029-SEI). These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09).

In addition to being sold in health food stores nationwide, Xiadafil VIP Tabs are also sold online and being given away as free samples in trade shows. These so called “all-natural” dietary supplements come in bottles of eight tablets or in blister cards of two tablets.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in an FDA news release that because these products are labeled as “all-natural dietary supplements,” consumers may assume that they are harmless and pose no health risk. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking,” added Woodcock.

The FDA fervently advises consumers not to take the recalled supplements. For those who have already made their purchases, consult a health professional if you’ve experienced any side effects, or report them to the FDA's MedWatch program.

For information about FDA-approved ED medications, health issues, wellness, and pharmacy solutions, log on to http://www.drugstoretm.com/ or call: 1-646-278-1136, Monday to Friday, 9:00am to 9:00pm (Pacific Standard Time).

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