FDA Warns Consumers About Unapproved Erectile Dysfunction Drugs

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Erectile dysfunction treatments are some of the most counterfeited drugs in the world, and on March 16, 2018, the FDA began warning consumers about dangerous unapproved drugs being advertised.

These counterfeit drugs are advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction. They have been advertised on broadcast and internet radio platforms such as iHeart Radio and can be dangerous to consumers as they have not been approved by the FDA.

Why are these counterfeit drugs dangerous?

Taking an unapproved drug can have serious health consequences like drug interactions and even death. These counterfeit medications have been found to contain 100mg of sildenafil, the generic and active ingredient of Viagra.  

Sildenafil is to be used with caution in patients with impaired liver and kidney function and interacts with prescription medications containing nitrates causing low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be unaware of the dangerous side effects if taken in combination with sildenafil.

It’s important to only take medications prescribed by your health care provider as they can determine if you have any contraindications that would prevent you from taking particular medications and potentially causing you harm or even death.  

How do I know if my Viagra is counterfeit?

The FDA warns that if you have purchased any medicine from the seller advertised on iHeart Radio or other venues that sell “healthy man alternatives to the little blue pill” or “healthy man” alternatives for erectile dysfunction, do not use these products. The FDA is also concerned the seller may also be distributing unapproved tadalafil as a generic for the prescription drug Cialis.  

The label on the blister packs for these unapproved drugs states that the products are manufactured in India by Acme Generics. The label also bears the name Sun Pharma.

Read here for more information on purchasing erectile dysfunction drugs safely.

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