Tainted Sexual Enhancement Supplements

  • 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.

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

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

  • 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.

  • Examples of products containing sildenafil.

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

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

  • 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.

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

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

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

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

  • 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.

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

  • 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.

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This slideshow contains images of tainted sexual enhancement products the FDA has investigated and deemed to have undeclared active ingredients.

While the FDA makes every effort to alert the public regarding tainted dietary supplements, it is up to the clinician to be aware of these products, and to have an open dialogue with their patients regarding sexual dysfunction and appropriate treatment.

Read our informative case study "Advising Male Patients on Sexual Supplements."