An article published in the Translational Andrology and Urology journal discusses the problems and dangers of counterfeit phosphodiesterase-5 inhibitors (PDE-5i) to treat erectile dysfunction (ED). PDE-5i is available in prescription form in the United States as an oral medication. It has become the first-line therapy and mainstay treatment option for the treatment of ED and other sexual dysfunctions.
Why is Counterfeit PDE-5i Popular?
With a cost of $20 to $30 per pill, some consumers have sought less expensive options to treat ED. Other consumers may not be opposed to the cost, but they do not want to go to the doctor, or they are embarrassed to seek treatment. Whatever, the reason, the market for counterfeit PDE-5i has grown very quickly in the United States and around the world. As the general population continues to age, the market for counterfeit PDE-5i could dramatically increase.
Another reason the market is growing is that the profit margin for counterfeit PDE-5i is very high. It is estimated that the profit margin for the ED medication is 2,000 times higher than it is for cocaine. Furthermore, the criminal punishment for buying the same amount of the counterfeit ED medication is usually three years compared to a minimum of five years up to 40 years for cocaine.
Other factors that contribute to the increased market for PDE-5i is the belief that self-regulating the use of PDE-5i is harmless, increasing incomes allow for the purchase of the medication, and increasing availability of sexual partners make it a recreational drug. Also, the ability to purchase PDE-5i from online pharmacies or other internet sources has helped increase the market for counterfeit drugs.
The Growing Problem of Counterfeit Drugs
Currently, there is not a conclusive definition of counterfeit drugs. However, the U.S. Food and Drug Administration (FDA) defines counterfeit medicine as “fake medicine” that could be contaminated, missing the active ingredient, or contain the wrong dosage of the active ingredient. The problem appears to be escalating with some sources estimating that the market for counterfeit drugs is somewhere between $75 and $200 billion.
Placing consumers at risk and in danger is the most concerning problem with counterfeit drugs. Pharmaceutical companies must test medications and submit evidence for approval to the FDA before a new drug is allowed on the market. After obtaining approval for a medication, the manufacturer must comply with strict and rigorous regulations, laws, and standards that govern the medications that are manufactured, distributed, and sold in the United States.
Counterfeit drug organizations bypass all safeguards designed to ensure medications are effective and safe for use. Without any oversight, counterfeit drug organizations can sell dangerous and potentially deadly medications; make widely false and misleading representations about medications; and, fail to disclose vital information that could prevent injury or death if the consumer had the information before taking the drug.
The Dangers of Counterfeit PDE-5i
PDE-5i has numerous known side effects that are clearly detailed in the packaging and literature distributed with legitimate prescription medications to treat ED. Furthermore, the use of PDE-5i in combination with other medications can create life-threatening conditions.
Physicians must carefully screen and evaluate patients, including reviewing all current medications, physical health, and medical conditions, before prescribing PDE-5i. When purchased through a counterfeit pharmacy or other organization, the medical evaluation is circumvented. Therefore, the person’s life could be in danger, and he does not realize this because he did not consult a physician.
In addition, ED has been linked to other medical conditions such as diabetes, hypertension, cardiovascular disease, hyperlipidemia, and metabolic syndrome. Men with ED need to be evaluated for an underlying or correlating medical condition. If they purchase counterfeit PDE-5i, they deny themselves potentially life-saving medical tests by a qualified physician.
Even with the above medical concerns, the fact that counterfeit drugs are completely unregulated is the most harmful problem with counterfeit PDE-5i. When analyzed, 2,383 samples of the counterfeit version of PDE-5i had absolutely no active ingredient, or up to 200 percent of the active ingredient recommended per dose. At the very least, the buyer could be receiving a product that will be ineffective. However, he could also be receiving a dose that could potentially result in severe side effects and potentially life-threatening drug interactions. Even if the dose is close to correct, the packaging for counterfeit PDE-5i is rarely labeled correctly, so the person may not know about the dangerous drug interactions and side effects.
Furthermore, because the drug is manufactured with absolutely no oversight or regulations, many of the counterfeit versions are contaminated. At the low end, the drugs have bulking agents to save money on production costs. Some contaminants could be dangerous and toxic. Other contaminants are introduced because the production is not sterile and may not even be sanitary.
Natural Supplements for the Treatment of ED
In addition to the counterfeit PDE-5i, you also have a market for natural or dietary supplements that are advertised to treat ED. These supplements are marketed as safe alternatives to prescription ED medications. However, some supplements contain higher than prescribed doses of prescription medications or other contaminants that make them just as dangerous as counterfeit PDE-5i. Therefore, using a dietary supplement or “all natural” treatment for ED can be just as dangerous.
See A Doctor
It is not safe to self-medicate for any condition. If you are experiencing the symptoms of ED, you should see your physician. Law enforcement agencies and government agencies attempt to stop dangerous drugs and dietary supplements from being sold; however, it is a difficult and almost impossible job to stop all counterfeiters and fraudulent companies. It is safer to obtain medication from a physician.