The Illicit Sale of Medications for the Treatment of Erectile Dysfunction

Philip J. Dorsey, Jr; Wayne J.G. Hellstrom, MD, FACS

Disclosures

Medscape Urology 

In This Article

Adulterated Herbal Medications

Natural or herbal treatments for erectile dysfunction are a popular alternative or adjunct to treatment with traditional pharmacologic agents. While the debate regarding the potential benefits and risks of herbal medications is ongoing, and their efficacy continues to be examined, there is no question that a significant number of these products are adulterated with undeclared synthetic pharmaceuticals such as PDE-5 inhibitors.[15] Clinicians and patients alike should be aware of the possibility that herbal medications may contain active ingredients not listed on packaging, which may result in pharmacologic interactions and unanticipated side effects.

Overall, the use of herbal remedies and dietary supplements has increased greatly over the past 40 years. Much of the increase in use can be attributed to the common belief that natural ingredients are inherently safer and healthier than synthetic ingredients.[15] Products sold as "dietary supplements" are subject to significantly less regulation and are often not required to have safety testing or FDA approval before they enter the market. Without adequate safeguards and quality-control mechanisms, there is no assurance that the concentrations of active ingredients are consistent from batch to batch or even that these supplements contain the ingredients they purport to contain. Furthermore, as a result of the scant monitoring and control of the production of these supplements, there are frequently no assurances that products are free of synthetic medications not included on the labels.

In fact, numerous studies of dietary supplements have shown that herbal remedies and dietary supplements often contain undocumented synthetic prescription adulterants which may have unknown effects on individuals who consume them. A study conducted by Laing and coworkers[16] found detectable levels of sildenafil, famotidine, ibuprofen, promethazine, diazepam, nifedipine, captopril, amoxicillin, and dextromethorphan in a sample of 200 herbal supplements advertised as being "all natural."[16]

Many investigators have shown that other purportedly "all-natural" dietary supplements claiming to improve sexual function actually contained synthetic PDE-5 inhibitors. In a study conducted by Gratz and colleagues,[15] half of 40 botanical products analyzed were found to contain undeclared synthetic PDE-5 inhibitors. Likewise, 28 of the 81 samples examined by Laing and colleagues[16] contained detectable levels of sildenafil.

Other studies have detected sildenafil, sildenafil analogs, tadalafil, and tadalafil analogs together in the same supplement.[17] These medications pose a particular risk for interactions as they contain combinations of different medications that act synergistically as well as analogues of PDE-5 inhibitors for which no clinical trials have been performed and no toxicologic profile is available.[17]

From these studies, it is clear that herbal supplements may not be as harmless as is generally thought. These supplements generally should not be taken together with other prescriptions for erectile dysfunction because of the risk of double dosing. Patients should be made aware of the potential for the adulteration of herbal supplements with undocumented active ingredients, such as PDE-5 inhibitors, particularly when they have contraindications for these active ingredients. Physicians must emphasize that patients, particularly high-risk patients, should discuss any treatment they initiate for their erectile dysfunction, and any reactions to these supplements should be carefully monitored.

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