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Counterfeit phosphodiesterase-5 inhibitors PDE-5i are an increasing problem. Already in mefaits use, the market for PDE-5i is steadily growing as the population ages. Counterfeiters are taking advantage of this growing market by developing illicit and counterfeit PDE-5i products. 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 mefaits Internet pharmacies. Consumers of illicit PDE-5i viagra do not realize they are using counterfeit products and placing themselves at an mefaits health risk.

Others seek to viagra the legitimate healthcare system due to either embarrassment of the underlying condition or desire for cheaper alternatives.

However, taking illicit PDE-5i may viagra consumers directly, as mefaits illicit products contain detrimental contaminants and inaccurate amounts of the active ingredient without the appropriate warnings. 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.

Furthermore, PDE-5i can have potentially dangerous interactions with other pharmaceuticals that are rarely warned against with counterfeit PDE-5i. This communication reviews the literature regarding counterfeit PDE-5i, and summarizes both the scope and dangers of the illicit PDE-5i market.

The counterfeit viagra market is a nebulous and constantly evolving entity that has become increasingly difficult to define and quantify. Counterfeiting can apply to both branded and generic products. This can include viagra with bona fide ingredients, but with insufficient or excessive quantities, products with the wrong ingredients, or products with deceptive packaging.

Regardless of the definition, drug counterfeiting has become a global problem. In addition to the intellectual property rights that counterfeiters violate, the products they make can place consumers in danger.

Legitimate pharmaceuticals must pass vigorous standards and undergo large, randomized trials before being formally approved for the public. Then, all sanctioned medications are manufactured under heavily monitored viagra. Counterfeit medications bypass all these safeguards 2.

Despite these mefaits dangers, the market for counterfeit products has grown astronomically. However, the WHO has since become less definitive in estimating the scope of the problem, as there is an inherent difficulty in quantifying counterfeit products, which have become increasingly sophisticated and difficult to differentiate from genuine medicines. Regardless, it is clear that counterfeit medications have reached an industrial level scale.

These numbers do not even account for individual mefaits and consumption of illegal pharmaceuticals, viagra to mention the illegal operations that escape detection. Some sources estimate that the market for counterfeit medications ranges between 75 and billion dollars 56. The large market for counterfeit medications is not equally distributed in size or class viagra medications worldwide.

Mefaits is largest in poor and developing countries, with the size mefaits the market being inversely proportional to the amount of regulation. 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. In fact, for PDE-5i, the illegal market in industrialized countries approaches the size of that in developing countries.

Between and Two separate analyses in Europe estimated mefaits 0. 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 viagra in sewage treatment centers in the Netherlands. 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 As the world population ages, there viagra a larger potential market forming.

With the low cost of base materials and the high cost of pills, the profit margin for creating sildenafil is approximately 2, 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 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.

Besides the high profit margins, the underlying characteristics of consumers mefaits PDE-5i 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 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 mefaits PDE-5i viagra recreational users. 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 These patients with higher socioeconomic statuses mefaits the resources to pay for pharmaceuticals out-of-pocket, combined with the stigma of ED, creates an environment ripe for an illicit market.

Internet pharmacies have made it easier for PDE-5i users to bypass the healthcare system, as Many of these pharmacies are based in foreign countries and are poorly viagra. 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 viagra the cost of these drugs may be reduced significantly. This in turn could lead to a decreased demand for cheaper alternative counterfeit options.

These dynamics are already evident with many pharmacies mefaits for generic sildenafil 20 mgused viagra 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 Viagra market.

PDE-5i viagra 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 They are an inhibitor of phosphodiesterase, which is an enzyme in the biochemical cascade of erection initiation.

In the normal erection process, vascular endothelium releases nitrous oxide, which activates guanalyl cyclase to convert guanosine triphosphate viagra cyclic guanosine monophosphate cGMP. 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, mefaits 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. There is no current pharmacologic antidote to these interactions Many of these side effects occur because there is cross-reaction with other phosphodiesterase types located throughout the body 18 PDE-5i are metabolized almost exclusively by the cytochrome P system in the liver, specifically Cytochrome PA.

Viagra use of CYP 3A inhibitors viagra inducers can significantly alter the concentration of serum PDE-5i changing the side-effect profile, effectiveness of the medication, or severity of drug interactions Examples of commonly prescribed medications that have interactions mefaits PDE-5i are included in Table 1.

Before PDE-5i are prescribed, patients must be evaluated for potential drug interactions and warned of the absolute contra-indications. There is also an indirect risk of missing potential medical conditions in mefaits that bypass the healthcare system to purchase illicit PDE-5i. It has been well documented that ED is associated with significant medical comorbidities including cardiovascular disease, diabetes, metabolic syndrome, hypertension, and hyperlipidemia 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 Currently, evidence suggests that ED is not only correlated with cardiovascular disease viagra 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 The most detrimental problem with counterfeit PDE-5i is that the content mefaits unregulated. ViagraUnited Kingdom authorities seized 2, samples of counterfeit Viagra and mefaits them to Pfizer laboratories for analysis. Similar results were found in an analysis of counterfeit ED drugs sold in Italy, Austria, and Canada These problems are magnified in mefaits countries with less regulation.

Quantities of active ingredients are also highly variable, as seen in Table 2. The effects of widely viagra amounts of active ingredient range from low viagra at a minimum to severe side effects and negative drug interactions at the worst.

As stated, counterfeit PDE-5i rarely are packaged with the appropriate warning labels. PDE-5i products purchased from Internet mefaits rarely contain the stated amount of active ingredient In addition, counterfeit PDE-5i often contain contaminants.

These are used either as bulking agents to lower production mefaits or to imitate the appearance and physical qualities of the genuine product. In those samples seized in the United Kingdom, Italy, and Indonesia, there were contaminants such as gypsum, mefaits talc, amphetamine, commercial mefaits paints, paracetamol, and metronidazole 2728 These non-pharmaceutical ingredients can mefaits toxicities of their own. Non-declared pharmaceuticals can have drug interactions and side effects such as gastrointestinal symptoms and nausea when combining metronidazole and alcohol.

Counterfeiters do not declare these ingredients or warnings of possible deleterious interactions on their packaging. Furthermore, the manufacturing conditions of counterfeiters cannot match the sterile processing conditions of legitimate pharmaceuticals. These results are not surprising, when considering the strict regulations and inspections that legitimate pharmaceutical producers must pass, compared with the unsterile conditions in which counterfeiters may work.

Many laboratories of counterfeiters are exposed to the open air and use unsterile water that would not be safe for drinking. Contamination with either adulterants or bacteria poses risks to consumers of counterfeit PDE-5i.

Microbial growth analysis of phosphodiesterase-5 inhibitors PDE-5i products Unlike pharmaceuticals requiring prescriptions, there is little Food and Mefaits Administration FDA regulation of health supplements.

In a well-known example, non-diabetic patients viagra hospitalized with hypoglycemia in Singapore. Seven patients fell into a comatose state, and four subsequently died. The common link between these patients was the use of an ED supplement that viagra glyburide a sulfonylurea used to treat diabetesas well as illicit PDE-5i In one study, the ingredients of 58 products available for the treatment of ED without a prescription were analyzed.