The Tribune

By DR GREGGORY PINTO

Viagra obtained US Food and Drug Administration (FDA) approval in March of 1998 and the world of erectile dysfunction has never been the same. The sexual enhancement pills industry is huge and continues to grow, with Viagra making over $2 billion last year. Other PDE5 inhibitor medications such as Cialis and Levitra are also widely prescribed throughout the world.

However, there is also a dubious industry of purported sexual enhancement pills that do not have FDA approval and are unregulated. These unregulated sex pills are potentially very dangerous to a man's health as they have not gone through rigorous testing, and the possible harmful health effects are numerous and very troubling. There is no data to support the safety or efficacy of these falsely advertised natural supplements.

A man should not trust a medication that he can buy from a cashier at the local gas station or hardware store, or over the internet. These medications are to be taken at one's own risk, but the average man has no idea what those potential negative health effects might be.

Rock Hard for Men pills were found in 2012 to contain counterfeit Cialis (tadalafil) and a diabetic drug that could prove deadly if misused. More than one dozen men died taking this drug in Asia in 2009.

In a Singapore study, more than three quarters of tested unregulated male enhancement pills contained chemicals that were not disclosed and more than half of the pills had doses of declared chemicals that were higher than recommended.

Earlier this year, the FDA issued specific warnings for multiple male unregulated sexual enhancements pills; some of which include the following:

• Stiff Nights

This supposed male sexual stimulant is marketed as a type of dietary supplement. The FDA has warned that these pills contain the chemical sulfoaidenafil which could dangerously lower a man's blood pressure and potentially have a deadly reaction with nitrate medications.

• Rock Hard Weekend

This unregulated male sexual enhancer also contains sulfoaidenafil and has the same potentially deadly side effect profile.

• Man Up Now

This product is marketed as an all natural and herbal enhancement medication but is far from natural and also contains the potentially dangerous sulfoaidenafil.

• Magic Power Coffee

This instant coffee product is not magical and is not 100 percent natural, as falsely advertised. It contains sulfoaidenafil and hydroxyhomosildenafil, which are chemicals very similar to those in Viagra. The product claims that horny goat weed and goji berries cause the extra mojo. The FDA has issued a strong warning against the use of this product.

• Mr Magic Male Enhancer from Don Wands

The FDA found this product to be far from magical and ordered that it no longer be made available as it contained the untested, dangerous chemicals sulfoaidenafil and hydroxyhomosildenafil.

• Duro Extend

This product had a complete recall by the FDA in December 2010, after it was determined that the marketed dietary supplement contained sulfoaidenafil, that is not a regulated chemical ingredient.

• Time Out Capsules

This product is marketed as being 100 percent natural but it also contains potentially dangerous sulfoaidenafil that could potentially cause sudden death in men taking nitrate medications.

• Vitalex

The founder of the company distributing Vitalex, Phu Tan Luong, is currently serving a prison sentence for Medicare fraud. This supposed all natural supplement contains acetildenafil, another untested rip-off of Viagra.

Many of the hundreds of unregulated pills marketed as natural male sexual enhancers can improve sexual function, but at what cost to a man's health and future?

The FDA has published strict warnings against the use of many of these pills and some brands have been recalled. These pills lack scientific studies and animal and human trials. 'Buyers beware' is the motto that must be adopted when using these unregulated products.

Many of these so called natural male enhancers actually contain chemicals that are dangerous rip-offs of the active ingredients in Viagra and other PDE5 inhibitor medications like Cialis and Levitra.

It is illegal to sell PDE5 inhibitor medications without providing a prescription from a licenced physician, who should have done a full evaluation of the patient and determined its use as safe and beneficial.

The US FDA regulates all drugs on the market but dietary supplements are only reviewed and monitored by the FDA. This loop hole in the regulatory regime of the FDA provides for all of these pills that are falsely advertised as being all natural or dietary supplements, to flood the market.

These unregulated male enhancers such as Rhino, that has more than 25 different pills marketed under the brand, are cheaper than regulated PDE5 inhibitors and do not require a man seeking assistance and evaluation from a licenced physician.

Several of the fake natural products do improve blood flow to the penis, but they also do untold harm to other organs such as the heart, kidneys, brain and liver.

Researchers have found rat poison, diabetic drugs, paint and lead in some of these dangerous unregulated, untested male enhancement pills.

Do not play Russian roulette with your life and your organs. Male erections require adequate penile blood supply and nerve supply and adequate levels of the male hormone testosterone and the right state of mind.

Underlying conditions such as undiagnosed or poorly controlled diabetes mellitus and hypertension, are often the culprits for erectile dysfunction in Bahamian men.

Erectile dysfunction often prompts many Bahamian men to seek urologist assistance and they are diagnosed for the first time with diabetes, hypertension, high cholesterol or cardiovascular disease. The diagnosis of these potentially debilitating conditions could prevent irreversible negative health effects for these men in the future.

Fake herbal supplements are only masking the potentially deadly underlying problem that lead to the erectile dysfunction.

There is a strong correlation between cardiovascular disease and erectile dysfunction. The occurrence of erectile dysfunction in some men should prompt investigation for cardiovascular disease, that potentially could prevent a cardiovascular event such as a stroke, heart attack or peripheral vascular disease of the legs.

Spinal, colorectal and prostate surgeries, amongst many more, could potentially disrupt the nerve supply to the penis.

At the age of 40, the male hormone testosterone falls on average 1 percent per year. Approximately 12 percent of middle aged men have low testosterone, hypogonadism.

Many medications potentially can interfere with erectile function.

Erectile dysfunction should be thoroughly investigated by an urologist and the underlying cause(s) should be determined, managed and reversed if possible.

There is nothing simple nor safe about taking unprescribed and unregulated male enhancements pills.

Seek the confidential, compassionate and comprehensive consult of an urologist in regards to your erectile dysfunction. You can always rise again.

• Dr Greggory Pinto is a board certified Bahamian urologist and laparoscopic surgeon trained in South Africa, Germany, and France. He can be reached at Urology Care Bahamas at the Surgical Suite, Centreville Medical Centre, #68 Collins Avenue/Sixth Terrace, Nassau. Call (242) 326-1929, e-mail welcome@urologycarebahamas.com, or visit the website www.urologycarebahamas.com.