Medication Monitor



Generic Name (Trade Name—Company)
Notes
March 27, 2018

Sildenafil, tadalifil

(Viagra, Cialis—Acme Generics)
FDA warns not to use unapproved erectile dysfunction products advertised on radio

FDA is warning consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by FDA.

These drugs, purchased without a prescription, contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients, including older adults and those with impaired liver and kidney function. When sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, a person’s blood pressure can reach dangerously low levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

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.

FDA is concerned the seller may also be distributing to U.S. consumers unapproved tadalafil as a generic for the prescription drug Cialis.

To date, FDA is not aware of any adverse events associated with these particular unapproved versions of sildenafil or tadalifil.