ISSUE: FDA lab analyses found Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men to contain sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. The active drug ingredients are not listed on the product label. Silenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Via Xtreme an unapproved drug.
BACKGROUND: The undeclared drug ingredients may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
RECOMMENDATION: Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/06/2011 - Press Release - Global Wellness, LLC]