Examples of packaging:
[3/16/2018] The U.S. Food and Drug Administration 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.
FDA confirmed that consumers have received these drugs, without a prescription, which contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients including the elderly 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.
If you purchased any medicines 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. If you have used these products and became ill or otherwise experienced an adverse event, contact your health care provider. FDA continues to warn consumers that medications purchased from unapproved and/or unlicensed sources may be dangerous as they can be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.
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. Health care professionals and consumers should report any adverse events related to this product to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.