Stiff Nights Contains Dangerous, Undeclared IngredientsNov 6, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Stiff Nights contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra.
Following a consumer complaint, the FDA determined that the product contains sulfoaildenafil and warns that sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and may cause dangerously low blood pressure.
"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”
Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant and use of such products exposes consumers to unpredictable risk and the potential for injury or even death.
Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs, and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.
Stiff Nights is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. Stiff Nights is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.
The FDA is advising 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 of these products should also be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at: www.fda.gov/MedWatch/report.htm]; by telephone, toll-free at 1-800-332-1088; by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm] by mail the address on the pre-addressed form; or by fax to 1-800-FDA-0178.