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Men looking online for "dietary supplements" to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.
"The number of these problematic products available on the Internet appears to be increasing," says Linda Silvers, leader of FDA's Internet and Health Fraud Team, part of the Office of Compliance (OOC) in the Center for Drug Evaluation and Research (CDER).
"Many consumers perceive these products as completely safe because they are often sold with labeling, suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED," she says. "But these products may be laced with potentially hazardous ingredients that aren't noted on the label."
Since 2004, FDA has become aware of several such "dietary supplements" (see sidebar for list).
Working with other FDA components, Silvers' team led an Internet survey in which more than one-third of purchased "dietary supplements" claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances.
"Six of the 17 products we bought contained sildenafil (the active ingredient in Viagra) or a substance similar to either sildenafil or vardenafil," says Silvers. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.
Mark Hirsch, a Medical Team Leader in CDER's Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.
"These products may interact in dangerous ways with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.
People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates, and men with these conditions commonly suffer from ED, Hirsch says. "Those are factors that doctors consider when prescribing approved ED treatments."
Silvers says FDA has determined that many of these products or their active ingredients are imported into the United States from other countries.
"FDA is working closely with U.S. Customs and Border Protection to develop a more effective network to successfully screen and stop these shipments from entering U.S. commerce," says Sally Eberhard, Acting Team Leader of OOC's Import-Export Team.
Silvers adds that the agency is also evaluating innovative ways to educate consumers about the risks of buying such sexual enhancement products and other drugs online.
Since 2004, FDA has identified several products sold online as so-called "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have contained potentially harmful, undeclared ingredients. Included among them are
FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products
www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html
FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements
www.fda.gov/bbs/topics/NEWS/2007/NEW01737.html
FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement
www.fda.gov/bbs/topics/NEWS/2006/NEW01409.html
FDA Warns Consumers Not to Use "Blue Steel" and "Hero" Products
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html
Date Posted: January 4, 2008
Updated: March 27, 2008
