In 2009, the World Health Organization (WHO) defined a “counterfeit medicine” as one “ which is deliberately and fraudulently mislabeled with respect to identity and/or source.” However, many in the organization have disputed this definition of counterfeit medicine, and there appears to be no universally agreed upon definition amongst member states of the WHO. The counterfeit drug market is a nebulous and constantly evolving entity that has become increasingly difficult to define and quantify. This communication reviews the literature regarding counterfeit PDE-5i, and summarizes both the scope and dangers of the illicit PDE-5i market. Furthermore, PDE-5i can have potentially dangerous interactions with other pharmaceuticals that are rarely warned against with counterfeit PDE-5i. Bypassing the legitimate healthcare system also endangers consumers indirectly, as erectile dysfunction (ED) is often associated with other medical comorbidities that patients should be screened for. However, taking illicit PDE-5i may harm consumers directly, as many illicit products contain detrimental contaminants and inaccurate amounts of the active ingredient without the appropriate warnings. Others seek to bypass the legitimate healthcare system due to either embarrassment of the underlying condition or desire for cheaper alternatives.

Consumers of illicit PDE-5i often do not realize they are using counterfeit products and placing themselves at an unnecessary health risk. Many factors are contributing to the rapid growth of the illicit market, such as the low risk of prosecution, potentially high financial reward, and ease of distribution via Internet pharmacies. Counterfeiters are taking advantage of this growing market by developing illicit and counterfeit PDE-5i products. Already in widespread use, the market for PDE-5i is steadily growing as the population ages. Counterfeit phosphodiesterase-5 inhibitors (PDE-5i) are an increasing problem.

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