FDA warns of using unapproved erectile dysfunction drug

FDA warns of using unapproved erectile dysfunction drug

The U. S. Food and Drug Administration is warning men with erectile dysfunction (ED) not to buy or use drugs advertised as a “healthy man alternative to the little blue pill,” “healthy man,” or “the power pill.” None of these products have been approved for use for ED by the FDA. Men should heed the manufacturer of the pill which is Acme Generics in India but the label may also bear the name Sun Pharma. 

The concern with these products is that they contain 100 milligrams (mg) of sildenafil, the active ingredient in Viagra.  Normally men will be prescribed 50 mg of Viagra making the dosage strength of 100 mg dangerous for certain men. This includes men who are elderly and those with impaired liver and kidney function.  The danger lies in that when sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, it can drop blood pressure to dangerously low levels.  Common users of nitrates include people with diabetes, high blood pressure, high cholesterol, or heart disease.

Men are learning about these pills primarily from broadcast and internet radio platforms such as IHeart Radio.  Any man who has purchased these pills is warned to not use them.  If they already have used the product and become ill or experience an adverse event, they need to contact their healthcare provider.  Men can also report any adverse event directly to the FDA’s Medwatch.

The FDA reminds consumers that purchasing medications from unapproved and/or unlicensed sources may be dangerous.  The reasons include the possibility of counterfeiting, contamination, medications improperly stored and transported, or medications which are deemed ineffective and/or unsafe.