A warning from a study review article summarizes the dangers men face if they choose counterfeit drugs to eliminate erectile dysfunction. This review brings to light the global problem of drug counterfeiting and the products produced placing consumers in danger unknowingly subjecting themselves to significant health risks.
The definition of a counterfeit medicine was defined in 2009 by the World Health Organization (WHO) as one “which is deliberately and fraudulently mislabeled with respect to identity and/or source.” However this definition has been disputed and at this time there is no universally agreed upon definition within WHO. Therefore, WHO is using the term “Substandard, Spurious, Falsely labeled, Falsified, and Counterfeit (SSFFC)” instead.
The growing market for counterfeit phosphodiesterase-5 inhibitors (PDE-5i)
The use of counterfeit drugs is always dangerous. Unlike legitimate pharmaceuticals which must pass vigorous standards and large, randomized trials before being approved for the public, counterfeit drugs do not undergo any sort of testing or scrutinizing of its effectiveness and safety.
Yet, the market for counterfeit drugs continues to grow rapidly despite the potential dangers. One large market demand for counterfeit medications is for counterfeit phosphodiesterase-5 inhibitors (PDE-5i). Examples of PDE-5i include Viagra, Cialis, and Levitra, all used for the treatment of erectile dysfunction. Sildenafil and tadalafil are also PDE-5i but are indicated for the treatment of pulmonary hypertension.
The demand for PDE-5i for erectile dysfunction is due to several reasons – erectile dysfunction (ED) is a common problem and increases in incidence as men age. With the world population aging, there is a larger potential market for ED medications. Also, there is a high economic gain to be made from counterfeit ED drugs. Another factor involved is the embarrassment many men have bringing up this problem with their doctor which leads patients to seek alternative means of obtaining PDE-5i for ED. The fact too that many of these counterfeit PDE-5i are advertised as “all natural” giving men the perception they are somehow safer than synthetic medications.
Recreational use is another reason for PDE-5i demand and the fact many users believe these drugs to be harmless and that they can be self-prescribed with no negative consequences. On top of this, internet pharmacies have made it very easy for men wanting to use a PDE-5i. This review showed that 68% of users did so without a prescription with 60% of these users falsely believing they were receiving the same product as from a legitimate pharmacy. Anyone doing a simple internet search for “internet drug store” will bring up 6.4 million hits and 7,000 Internet pharmacies. Of these pharmacies, only 4% were in compliance of the Verified Internet Pharmacy Practice Sites program.
Why counterfeit PDE-5i can be dangerous
To understand the dangers of PDE-5i, one has to have a basic understanding of how they are used. The purpose of PDE-5i is to inhibit phosphodiesterase, an enzyme in the biochemical cascade of erection initiation. When a man achieves an erection normally, vascular endothelium release nitrous oxide that activates several processes that lead to vasodilation and an erection. PDE-5i help lead the process to sustained vasodilation.
There are many reasons why use of counterfeit PDE-5i can be dangerous. They can result in the following situations:
· Dyspepsia or indigestion
All patients who are planning on taking any prescription medications need to be evaluated by their physician for potential drug interactions with other medications they are taking. Another danger is the indirect risk of missing potential medical conditions in patients who bypass the healthcare system to purchase illicit PDE-5i. Men who have ED have also been known to be at a greater risk of other significant medical conditions including cardiovascular disease, diabetes, metabolic syndrome, hypertension, and hyperlipidemia.
Another concern with counterfeit PDE-5i is the fact that the content of them is unregulated. In 2009, over 2300 samples of counterfeit Viagra were seized by United Kingdom authorities and had them analyzed by Pfizer laboratories. The concentration of active sildenafil ranged from 1-200% of indicated strength and only 10% of the samples contained an active ingredient within 10% of what was advertised on the packaging.
How are counterfeit PDE-5i being limited?
There have been several means of trying to limit the distribution and sale of counterfeit PDE-5i over the years:
· In 2006, WHO created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to help build coordinated networks across and between countries to halt the production, trading, and selling of counterfeit medications around the world.
· PDE-5i manufacturers have started working with regulatory and law enforcement authorities to provide distinctive packaging using holographic security foil, 2D barcodes, and radio frequency identification tags.
· The Food and Drug Administration (FDA) has launched significant public education campaigns through magazine public service announcements, education leaflets, news articles, a consumer website (www.fda.gov/counterfeit), and a pharmacist education program.
· Healthcare providers are encouraged to educate patients on the risks of counterfeit and other non-FDA approved products reminding them to only purchase from VIPPS-certified pharmacy if they want to fill prescriptions online and to report any suspected cases of counterfeit medicines to the FDA.
In the meantime, men should not rely on purchasing any ED medications online without checking with their physician first on the safety of the website selling them. When men are educated and understand the health ramifications of using PDE-5i drugs that are counterfeit, they can avoid potential side effects of improper dosing and contaminants placing them at a dangerous risk to their health and well-being.