FDA Orders ED Supplement Recall

May 27, 2008 -- Due to a risky ingredient, the FDA has ordered a recall of certain lots of Xiadafil VIP Tabs, an illegally marketed "all-natural" dietary supplement touted for sexual enhancement and erectile dysfunction (ED) treatment.

FDA lab tests show that the recalled supplements contain hydroxyhomosildenafil, which is similar to sildenafil, Viagra's active ingredient.

Hydroxyhomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels, notes the FDA.

The FDA, which hasn't approved Xiadafil VIP Tabs for erectile dysfunction or any other drug use, 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).

The supplements are sold online, given away as free samples at trade shows, and are sold in health food stores nationwide. They come in bottles of eight tablets or in blister cards of two tablets.

"Because these products are labeled as 'all-natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in an FDA news release. "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."

The FDA's advice: Stop taking the recalled supplements, consult a health professional if you've experienced any side effects, report side effects to the FDA's MedWatch program, and if you've got ED, talk with a health care professional about FDA-approved treatments.