Product Liability

FDA warns consumers about herbal enhancement pills

The U.S. Food and Drug Administration warned consumers yesterday that the dietary supplement Stiff Nights contains sulfoaildenafil, a chemical compound similar to sildenafil, the active ingredient found in Viagra. When combined with prescription nitrates, including nitroglycerin, sildenafil can cause blood pressure to drop dangerously.

Stiff Nights is manufactured by Impulsaria LLC of Grand Rapids, Michigan. It is sold in retail stores and on various websites in bottles containing 6, 12, or 30 red capsules. The product is also available in blister packs that contain one or two capsules.

According to the product’s website, Stiff Nights “works using natural ingredients to stimulate blood vessels, increase blood flow to the genitals, and special herbal extracts that help make the body feel sexually aroused and excited.”

Because it is made with herbs and other natural ingredients, the product is not regulated by the FDA. Consumers should avoid using natural supplements, including sexual enhancement remedies, that are unapproved by the FDA, as these substances can interact with other drugs, causing unwanted side effects, or may exacerbate certain medical conditions.

The FDA says that sexual enhancement products that claim to work as well as prescribed drugs “are likely to contain a contaminant.”

“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.”

“Use of such products exposes consumers to unpredictable risk and the potential for injury or even death,” the FDA said.

According to the FDA, over the last several years it 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.

The FDA advises anybody who has experienced adverse events as a result of taking sexual enhancement products to see a health care professional. Side effects and negative reactions should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which can be accessed online at http://www.fda.gov/MedWatch/report.htm/. The information can also be reported by phone by calling the program at 1-800-332-1088.

The MedWatch web site also contains a section of postage-paid downloadable forms that may be filled out and returned to the FDA by mail to the address on the pre-adressed form or by fax (1-800-FDA-0178).

The FDA issued its warning about Stiff Nights after receiving reports of adverse events caused by the product.