FDA Finds Yet More ED Agents Unsafe

The FDA has added two additional "dietary supplements" to its list of unapproved drugs being sold to treat erectile dysfunction, or ED.

Consumers are being warned not to purchase or use "Blue Steel" and "Hero," distributed by Active Nutraceuticals or the Marion Group in Carrollton, Ga., according to a March 25 FDA news release. The products are considered illegal drugs because they have not been proven safe or effective and because they contain undeclared ingredients, including substances similar in chemical structure to sildenafil, the FDA found.

Sildenafil is the active ingredient in prescription drugs for ED. The similar compound found in Blue Steel and Hero may interact with nitrate-containing prescription medications, such as nitroglycerin, commonly prescribed to control symptoms associated with diabetes, high blood pressure, high cholesterol or heart disease. ED is common in men with these medical conditions, the release said.

"Because they may have been advised against taking ED drugs, these men may seek products like Blue Steel or Hero because the products are marketed as 'all natural' or as not containing the active ingredients in approved ED drugs," the FDA statement warned.

Previously, the FDA has warned of the dangers of 25 other unsafe products marketed as treatments for ED or sexual enhancement and available for sale online. The FDA now provides a clearinghouse of information on these dangerous ED products. Each of these products contains either undeclared ingredients; prescription drug ingredients, including sildenafil or vardenafil (the active ingredient in Levitra); or analogs of the active ingredients in these two prescription drugs.

In addition to asking patients to avoid these ED products, physicians are encouraged to report adverse events to MedWatch by calling (800) FDA-1088 or via the MedWatch Web site.

The number of such problematic products available online is increasing, according to the FDA. The popularity of and potential dangers posed by these products underscore the importance of talking with patients about any complementary or alternative therapies they use.

To that end, free materials are available for doctors and consumers through the "Time to Talk" campaign sponsored by the National Center for Complementary and Alternative Medicine, or NCCAM. Among other resources, this NCCAM initiative provides toolkits designed to help prompt discussion on the use of alternative medicines.