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FDA Issues Safety Warnings on ‘Male Enhancement’ Products

Agency notes growing trend of dietary supplements with hidden chemicals (Mar. 21)

The FDA has announced that three “male enhancement” products contain hidden prescription drug ingredients and could be dangerous. The FDA is advising consumers not to purchase or use the products “Stiff Days,” “Rock-It Man,” and “Libido Sexual Enhancer,” which are promoted and sold on various Web sites and in some retail stores.

FDA laboratory analysis confirmed that “Stiff Days” contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra (Pfizer), which is used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, the FDA says. Men with diabetes, hypertension, high cholesterol, or heart disease often take nitrates.

“Rock-It Man” contains the undeclared ingredient hydroxythiohomosildenafil, which is structurally similar to sildenafil.

“Libido Sexual Enhancer” contains the undeclared ingredients hydroxythiohomosildenafil, hydroxyhomosildenafil, sildenafil, and tadalafil. Like hydroxythiohomosildenafil, hydroxyhomosildenafil is structurally similar to sildenafil. Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis (Eli Lilly), which, like sildenafil, is used to treat ED. All of these undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.

According to the FDA’s warnings, consumers should stop using these products immediately and throw them away. Consumers who have experienced any adverse side effects should consult a health care professional as soon as possible.

The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products.

The agency notes a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” The FDA says that it is unable to test and identify all products marketed as dietary supplements. Consumers are therefore advised to exercise caution before purchasing any product in the above categories.

Source: FDA; March 21, 2013.

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