Potential Health Risks and Side Effects

Examples of commonly prescribed medications that have interactions with PDE-5i are included in Table 1.

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Internet pharmacies have made it easier for PDE-5i users to bypass the healthcare system, as 16.5% of PDE-5i users obtained the medicine through the Internet (13). Of these users, 68% did so without a prescription, as patients often do not realize that they are getting false and possibly dangerous products, and 60% of these users believed they received the same product as from a legitimate pharmacy (13). A simple sex tablet 100mg Internet search for “internet drug store” revealed 6.4 million hits and 7,000 Internet pharmacies. Of these “pharmacies,” only 4% were in compliance of the Verified Internet Pharmacy Practice Sites (VIPPS) program (16). Many of these pharmacies are based in foreign countries and are poorly regulated.

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In a random search of Internet pharmacies for Viagra (Pfizer, New York City, New York, USA), 90% of these Internet pharmacies offered illegal “generic Viagra.” No pharmacy required a prescription or a health screening survey for purchase, and the products lacked product information, appropriate safety warnings, and genuine Viagra formulations. In fact, only 18% of Internet-ordered “Viagra” was genuine (17). The ease and convenience of purchasing counterfeit PDE-5i products via the Internet have contributed to the growth of the illicit market. While the market for counterfeit pro-erectile medications is partially driven by the cost of prescription drugs, this reality could soon change. As the patents for PDE-5i will be expiring soon, it is conceivable that the cost of these drugs may be reduced significantly.

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This in turn could lead to a decreased demand for cheaper alternative counterfeit options. These dynamics are already evident with many pharmacies advertising for generic sildenafil (20 mg), used for pulmonary hypertension, at a significantly lower cost. Furthermore, as mentioned earlier, embarrassment with potency issues leads patients to avoid physician visits. PDE-5i have been shown to be safe medications and may ultimately be available over the counter. This strategy could help ease patient concerns and re-invigorate the PDE-5i market. Before PDE-5i are prescribed, patients must be evaluated for potential drug interactions and warned of the absolute contra-indications.

Ingredient	Function	Typical Dosage	Possible Side Effects
Sildenafil	Enhances blood flow	50-100 mg	Headache, flushing, dizziness
Tadalafil	Prolongs erection	10-20 mg	Muscle aches, nasal congestion
L-Arginine	Increases nitric oxide production	500-3000 mg	Gastrointestinal discomfort
Yohimbine	Stimulates nerve activity	5-15 mg	Anxiety, increased heart rate
Panax Ginseng	Boosts stamina and energy	200-600 mg	Insomnia, headaches

There is also an indirect risk of missing potential medical conditions in patients that bypass the healthcare system to purchase illicit PDE-5i.

Product	Dosage	Quantity + Bonus	Price
Kamagra Gold	100 mg	20 Pills	86.09€ 81.99€	Buy
Viagra Generic	25mg	180 + 6 Pills	154.93€ 147.55€	Buy
Tadalista Super Active	20mg	60 + 8 Pills	230.32€ 219.35€	Buy
Cialis Generic	2.5mg	10 Pills	28.51€ 27.15€	Buy
Kamagra Gold	100 mg	360 + 6 Pills	839.95€ 799.95€	Buy
Viagra Original	100mg	34 + 2 Pills	163.67€ 155.88€	Buy
Kamagra Soft Tabs	100 mg	32 Pills	120.11€ 114.39€	Buy
Viagra Generic	200mg	360 + 10 Pills	481.98€ 459.03€	Buy
Viagra Generic	50mg	20 Pills	40.52€ 38.59€	Buy
Viagra Generic	150mg	180 + 10 Pills	236.46€ 225.20€	Buy
Viagra Professional	100mg	180 + 4 Pills	337.30€ 321.24€	Buy

It has been well documented that ED is associated with significant medical comorbidities including cardiovascular disease, diabetes, metabolic syndrome, hypertension, and hyperlipidemia (23).

Factor	Impact	Recommendations
Diet	Fatty foods may delay absorption	Take pills on an empty stomach for faster effect
Alcohol Consumption	Can reduce effectiveness, cause side effects	Limit or avoid alcohol before use
Exercise	Improves blood flow, enhances results	Maintain regular physical activity
Sleep	Affects overall performance	Ensure adequate rest

The Second Princeton Consensus on sexual dysfunction and cardiac risk stated that all men with ED, even in the absence of manifesting cardiac symptoms should be regarded as having potential risks for cardiovascular disease (24).

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Currently, evidence suggests that ED is not only correlated with cardiovascular disease due to shared medical comorbidities, but is, in fact, an independent risk factor for cardiovascular disease. Thus, all men with vasculogenic ED should undergo cardiac risk stratification and risk factor management (25). In an analysis of 24,708 patients receiving a PDE-5i, 70% had an underlying medical diagnosis, with 50% of these patients having vasculogenic disease. Furthermore, 11.5% of patients being evaluated for a PDE-5i prescription had a new underlying disease detected (26). The most detrimental problem with counterfeit PDE-5i is that the content is unregulated.

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As the world population ages, there is a larger potential market forming. Furthermore, the cost of a single PDE-5i pill is priced upwards of $20–30. With the low cost of base materials and the high cost of pills, the profit margin for creating sildenafil is approximately 2,000 times that of cocaine. Meanwhile, while the punishment for buying 1 kilo of cocaine would be a minimum of 5 years to a maximum of 40 years in jail, the punishment for buying 1 kilo of sildenafil is typically 3 years (11). With such significant profits to be made at a relatively low risk, there is a tremendous incentive for counterfeiters to tap into the growing market for PDE-5i.

Table 1. Common medications and dietary supplements with interactions with phosphodiesterase-5 inhibitors (PDE-5i).

Besides the high profit margins, the underlying characteristics of consumers of PDE-5i fildena 150 mg tablet make it a prime target for counterfeiters. There is an associated embarrassment of the underlying condition of impotence that leads patients to seek alternative means of obtaining PDE-5i (12). In two large surveys, 23–32% of PDE-5i users had no prior interactions with healthcare professionals (13,14). Predictive factors for obtaining PDE-5i while avoiding interaction with healthcare professions were embarrassment and the perception that it would be cheaper to get the medicine through alternative means. Furthermore, many users of PDE-5i are recreational users.

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In those same surveys, 16–36% of reported users did not report ED (13,14). These statistics speak to the underlying idea that users believe PDE-5i are harmless and that they can be self-prescribed, with no negative consequences. Furthermore, PDE-5i use is a relative luxury. Increasing household income and availability of a sexual partner positively correlate with their legal use (15). These patients with higher socioeconomic statuses having the resources to pay for pharmaceuticals out-of-pocket, combined with the stigma of ED, creates an environment ripe for an illicit market. In 2009, United Kingdom authorities seized 2,383 samples of counterfeit Viagra and forwarded them to Pfizer laboratories for analysis.

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The concentration of active sildenafil ranged from 0–200% of indicated strength, and only 10% of the samples contained an active ingredient within 10% of what was advertised on the packaging (27).

Risk	Description	Precautionary Measures
Blood Pressure Fluctuations	Sudden changes in blood pressure	Consult doctor if hypertensive
Allergic Reactions	Hives, swelling, difficulty breathing	Discontinue use, seek medical attention
Drug Interactions	Interactions with nitrates or certain medications	Always check with healthcare provider
Dependence Risk	Psychological reliance on pills	Use as directed, avoid overuse

Similar results were found in an analysis of counterfeit ED drugs sold in Italy, Austria, and Canada (28).

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There is no current pharmacologic antidote tadalis sx 20 mg to these interactions (21). Other side effects include headache, dyspepsia, flushing, myalgia/back pain, visual disturbances, and nasal congestion. Many of these side effects occur because there is cross-reaction with other phosphodiesterase types located throughout the body (18,22). PDE-5i are metabolized almost exclusively by the cytochrome P 450 system in the liver, specifically Cytochrome P4503A. Concurrent use of CYP 3A inhibitors or inducers can significantly alter the concentration of serum PDE-5i changing the side-effect profile, effectiveness of the medication, or severity of drug interactions (21). These problems are magnified in developing countries with less regulation.

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In order to understand the dangers of PDE-5i, it is important to first understand how PDE-5i are used. PDE-5i are effective in treating ED of many etiologies, and are currently both the first line and mainstay treatment option. Studies have suggested that PDE-5i are also effective in treating premature ejaculation, decreasing refractory time post-ejaculation, and diminishing lower urinary tract symptoms (18). They are an inhibitor of phosphodiesterase, which is an enzyme in the biochemical cascade of erection initiation. cGMP then acts on protein kinase G to open calcium channels that leads to vasodilation and an erection.

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Phosphodiesterase-5 acts to convert cGMP to GMP, which interrupts this chain and leads to detumescence (19,20). Thus, PDE-5i prevent cGMP from being metabolized, leading to sustained vasodilation. There are numerous known side effects of PDE-5i, some of which may be life threatening. As PDE-5i are active in the vasodilation pathway, there is a risk of profound hypotension and syncope with concurrent use of nitrates and alpha-blockers. The use of nitrates is an absolute contra-indication to PDE-5i use and the use of alpha-blockers is a relative contraindication. In Indonesia, 100% of “Viagra” sold by street peddlers, 56% purchased in “drug stores”, and 13% acquired from legitimate pharmacies was counterfeit Viagra marked as authentic (29). In pills marked as 100 mg, 64% contained <50 mg, 25.5% contained between 50–95 mg, and only 4.7% contained between 95 to 105 mg; 5.7% contained >105 mg (30).

Other sources

The large market for counterfeit medications is not equally distributed in size or class of medications worldwide. It is largest in poor and developing countries, with the size of the market being inversely proportional to the amount of regulation. The proportion of falsified drugs ranges from 1% in industrialized countries that have a well-regulated and controlled drug market to as high as 60% in some developing countries (6). However, even in these well-regulated countries, the market for counterfeit PDE-5i has grown. Globally, antibiotics comprise the largest class of counterfeit medications, but in Europe, PDE-5i are the most commonly counterfeited medicines (7).

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In fact, for PDE-5i, the illegal market in industrialized countries approaches the size of that in developing countries. Between 2004 and 2008, 35.8 million counterfeit sildenafil tablets were seized in Europe, which is 7 times greater than the amount of all other counterfeited Pfizer products combined. Two separate analyses in Europe estimated that 0.6 to 2.5 million men are being exposed to illicit sildenafil compared to approximately 2.5 million users of legal sildenafil (8). However, the true scope of illicit PDE-5i use is difficult to estimate. In one study attempting to estimate illicit sildenafil use, concentrations of sildenafil and sildenafil metabolites were measured in sewage treatment centers in the Netherlands.

Table 2. Analysis of phosphodiesterase-5 inhibitors (PDE-5i) purchased from the Internet.

The total sewage load was back calculated to estimate total sildenafil consumption, and it was found that greater than 60% of identified sildenafil was not accounted for by legal prescriptions (9). Many factors contribute to the disproportionately large market of counterfeit PDE-5i. First, there are high economic gains to be made. Erectile dysfunction (ED) is a common problem and increases in incidence as men age (10). According to the Massachusetts Male Aging Study, 52% of men aged 50–70 have some degree of ED, a number that increases to upwards of 70% in men older than 70.