FDA warns consumers on sexual enhancement products

November 19, 2009

The 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.

The 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.

Following a consumer complaint, the FDA determined that the product contains sulfoaildenafil, a chemical similar to sildenafil (Viagra). Sulfoaildenafil may interact with nitrates, including nitroglycerin, and cause dangerously low blood pressure.

The product is distributed on Internet sites and at retail stores by Impulsaria LLC (Grand Rapids, MI). It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

"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, of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications."

In response to the FDA warning, AUA issued a statement warning patients about the use of herbal supplements for sexual dysfunction and other urologic conditions.

"In recent years, data have shown that herbal supplements may be unreliable or even dangerous when used to treat urologic diseases," said J. Quentin Clemens, of AUA’s Quality Improvement & Patient Safety Committee. "Drugs such as sulfoaildenafil may interact with prescription drugs containing nitrates and produce dangerously low blood pressure in some patients. It is most important that patients understand that their health could be at risk if they do not discuss with their physicians any supplement regimen prior to starting."