Tainted Sexual Enhancement Supplements

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  Over 330 dietary supplements containing undeclared active ingredients have been identified by the FDA over the past five years. These products claim to be "all natural" alternatives to prescription drugs.

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  Sexual performance enhancement products are among the fastest growing category of tainted supplements.

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  Patients may choose these products to avoid an embarrassing discussion with their healthcare provider or to avoid the cost of an office visit.

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  Sildenafil (Viagra; Pfizer), tadalafil (Cialis; Lilly), and vardenafil (Levitra; GSK & Bayer), products FDA-approved for erectile dysfunction, have been detected in many of these supplements.

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  Examples of products containing sildenafil.

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  The amount of sildenafil, however, cannot be ascertained. FDA tests have shown some products to have enormous quantities of drug, higher than approved dosages.

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  Novel pharmaceuticals that are analogues of these prescription products are also being added to supplements.

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  Currently, there are more than 45 analogues. These include aminotadalafil, dimethylacetidenafil, hydroxyhomosildenafil, hydroxythiohomosildenafil, and sulfosildenafil. There is no human safety data available for these analogues.

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  PDE-5 inhibitors and their analogues can interact with some prescription drugs such as nitroglycerin which may lower blood pressure to dangerous levels.

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  Patients unaware of a product’s hidden ingredient may put themselves at serious risk.

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  Enforcement actions and consumer advisories only cover a small fraction of tainted OTC products on the market.

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  Healthcare professionals should make an effort to learn what dietary supplements their patients are using.

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  If a patient shows interest in improving his erectile function, it may be appropriate to prescribe an FDA-approved product that has been tested, rather than an unregulated dietary supplement elsewhere.

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  If a sexual enhancement supplement produces its desired effect, the odds are it contains an undeclared ingredient.

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  Healthcare professionals should try to obtain samples of potentially tainted product and report the case to the FDA. Visit www.FDA.gov for more information.