PRACTICE RESOURCES > Patient Safety & Quality of Care > FDA Alerts and Recalls

AUA Issues Statement about Herbal Supplements Following FDA Safety Alert

On Friday, November 6, the U.S. Food and Drug Administration (FDA) issued a statement warning patients that the product Stiff Nights, a dietary supplement, contains sulfoaildenafil (an analog of the phosphodiesterase inhibitor sildenafil). The drug has not been approved by the FDA.

In recent years, data have shown that herbal supplements may be unreliable or even dangerous when used to treat urologic diseases. 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.

The AUA feels that it is incumbent upon physicians around the country to educate their patients about the risks associated with herbal supplements. Herbal products, food supplements and nutriceuticals are not reviewed or approved by the FDA. The consumer must trust the manufacturer's statement about the ingredients of a product and the safety of those ingredients. It is very important for consumers to know that supplements are not subject to any sort of review or study prior to market release. Supplement manufacturers are responsible for ensuring that a dietary supplement is safe prior to it being marketed, and that product label information is truthful and not misleading. The FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market.

The above statement, issued on November 9, 2009, is attributable to J. Quentin Clemens, MD, chair of the AUA Quality Improvement & Patient Safety Committee.

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