Caution about Sexual Enhancement Products

FDA Consumer Corner

You can easily find them on the internet - products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make you think they're harmless. But they may not be.


FDA has found that many of these supposedly "all natural" products actually contain ingredients that aren't on the label, and these ingredients could lead to serious and even fatal effects.


An FDA investigation of a number of these sexual enhancement supplements found that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl.

Stiff Nights - product contains undeclared drug ingredient

Audience: Consumers, Pharmacists

[Posted 11/05/2009] FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. 


Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules. 

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. 


Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[11/05/2009 - News Release - FDA]
[11/05/2009 - Hidden Risks of Erectile Dysfunction "Treatments" Sold Online - FDA Consumer Updates]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm