Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks

Abstract

Counterfeit drugs are inherently dangerous and a growing problem; counterfeiters are becoming increasingly sophisticated. Growth of the counterfeit medication market is attributable in part to phosphodiesterase type 5 inhibitor (PDE5i) medications for erectile dysfunction (ED). Millions of counterfeit PDE5is are seized yearly and account for the bulk of all counterfeit pharmaceutical product seizures. It has been estimated that up to 2.5 million men in Europe are exposed to illicit sildenafil, suggesting that there may be as many illegal as legal users of sildenafil. Analysis of the contents of counterfeit PDE5is shows inconsistent doses of active pharmaceutical ingredients (from 0% to > 200% of labelled dose), contaminants (including talcum powder, commercial paint and printer ink) and alternative ingredients that are potentially hazardous. In one analysis, only 10.1% of samples were within 10% of the labelled tablet strength. Estimates place the proportion of counterfeit medications sold over the Internet from 44% to 90%. Of men who purchase prescription-only medication for ED without a prescription, 67% do so using the Internet. Counterfeit PDE5is pose direct and indirect risks to health, including circumvention of the healthcare system. More than 30% of men reported no healthcare interaction when purchasing ED medications. Because > 65% actually had ED, these men missed an opportunity for evaluation of comorbidities (e.g. diabetes and hypertension). Globally, increased obstacles for counterfeiters are necessary to combat pharmaceutical counterfeiting, including fines and penalties. The worldwide nature of the counterfeit problem requires proper coordination between countries to ensure adequate enforcement. Locally, physicians who treat ED need to inform patients of the dangers of ordering PDE5is via the Internet.

Figure 1

Sildenafil dosage of counterfeit products (n= 316) analysed by Pfizer Samples were labelled as ‘Viagra 100 mg’

Figure 2

Distribution of men who interacted within or outside the healthcare system (HCS) to obtain phosphodiesterase type 5 inhibitors by (a) country and (b) age. A chi-square test was used to test associations, statistical tests were two-tailed, and the Bonferroni-Holm sequential step-down method was applied to control the overall alpha level, set at 0.05

Figure 3

Attitudes towards phosphodiesterase type 5 inhibitors obtained via the Internet. ED, erectile dysfunction; HCP, healthcare professional. Reproduced from Schnetzler et al. (37) with permission from Blackwell Publishing Ltd.