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FDA warns consumers against unapproved erectile dysfunction drugs

The US Food and Drug Administration (FDA) has issued a warning to consumers about unapproved erectile dysfunction drugs advertised nationwide on broadcast and internet radio platforms. The products, advertised on iHeartRadio and other stations, have been advertised as a “healthy man alternative to the little blue pill” or “healthy man” or “the power pill”. 

Consumers who purchased the products as alternatives to approved prescription erectile dysfunction medication have been advised not to use the drugs and to contact a healthcare provider if use of the product has caused an adverse event or illness. The unapproved medication contains a 100 mg dose of sildenafil, a phosphodiesterase-5 inhibitor indicated for the treatment of erectile dysfunction and which is the active ingredient in Viagra.

In August 2017, IMS data reported that annual sales of the branded version of Viagra topped $1.4 billion in the United States. However, in December 2017 generic versions of the drug went on sale in pharmacies across the country. Generic versions were released by Pfizer, the original manufacturer of the drug, and generic pharmaceuticals firm Teva Pharmaceuticals. In both cases, the generic drugs are available at a significantly lower price than the branded version. 

The FDA warned the dosage contained in the unapproved erectile dysfunction products could be particularly dangerous for certain people, particularly elderly patients. Others at risk include patients with impaired kidney or liver function, and those on certain other prescription medications, notably those containing nitrates. 

Nitrate-containing medication - such as nitroglycerin or Dilatrate (isosorbide) - works by widening blood vessels, but can interact with sildenafil, resulting in dangerously low blood pressure levels. These drugs may be prescribed to treat a range of common ailments, including diabetes, high cholesterol, high blood pressure (hypertension), and heart disease. 

Among the identifying features of the affected medication is the label on the blister packs, which states the products are manufactured in India by Acme Generics and bears the name Sun Pharma. The agency also expressed concern that the vendor of the medication is also distributing an unapproved form of tadalafil as a generic version of the prescription erectile dysfunction medication Cialis.