Do not use Big Penis, regulators warn: 'Natural' sex stimulant contains undeclared Viagra ingredient that could leave unwitting users with dangerously low blood pressure

  • The product, promoted as a natural male sexual stimulant, is available online and does not require a prescription
  • But it contains sildenafil, which is so potent it requires a doctor's approval

By MIA DE GRAAF HEALTH EDITOR FOR DAILYMAIL.COM

Published: | Updated:

Do not use Big Penis, US regulators are warning Americans.

The product, promoted as a natural male sexual stimulant, is available online and does not require a prescription.

But inspectors with the Food and Drug Administration (FDA) found the tablets, sold globally, contain undeclared sildenafil - the active ingredient in Viagra - which is so potent it requires a doctor's approval.

While that may be welcome news to some users, health officials warn the powerful ingredient could lower blood pressure to dangerous levels, with sinister consequences for users with conditions such as diabetes or heart disease.

Doctors are the gatekeepers for sildenafil, primarily because many men with erectile dysfunction also have heart problems, and are likely on medications that might interact with sildenafil

Doctors are the gatekeepers for sildenafil, primarily because many men with erectile dysfunction also have heart problems, and are likely on medications that might interact with sildenafil

When it comes to the actual impact of popping unregulated pills of sildenafil, it's uncharted territory. 

The drug works by dilating blood vessels to improve blood flow to the penis; it can also be prescribed to lower blood pressure in the lungs.    

But US regulators determined in the 90s that a doctor was needed as gatekeeper for the ingredient, primarily because many men with erectile dysfunction also have heart problems, and are likely on medications that might interact with sildenafil.   

'We are learning more and more than erectile dysfunction could be a harboring of cardiac problems in the future,' Dr Premal Patel, a urologist at the University of Miami, told DailyMail.com in a recent interview. 

'The same blood vessels providing blood to the heart [provide blood to] the penis.'

As a urologist, he says, it's part of the job to check patients' heart health too, and to be aware that drugs like Cialis or Viagra 'have side effects if you take them with medication.'

In the FDA warning, issued this week, regulators urged any patients who've suffered side effects after taking Big Penis to report it on their interactive form. 

 

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