The U.S. Food and Drug Administration is warning the public about a sexual enhancement drug that has been discovered to contain an undeclared ingredient. While technically FDA-approved, the undeclared drug may cause adverse effects if it interacts with prescription drugs.

FDA Warning About ‘Big Penis’

The FDA discovered the male sexual stimulant "Big Penis" while inspecting international shipments. Upon testing, however, the FDA found that Big Penis contains an undeclared drug that may be dangerous to those taking it.

Evidently, Big Penis contains undeclared sildenafil, which is the active ingredient in Viagra. While sildenafil is FDA-approved for the treatment of erectile dysfunction, having it undeclared in a drug is rather dangerous because sildenafil may interact with the nitrates in some prescription drugs such as those for diabetes, high blood pressure, heart disease, and high cholesterol. When it does interact, it may lower the drug taker’s blood pressure to dangerously low levels.

The agency is advising people not to buy or use the drug, and is encouraging medical professionals and members of the public who did to report any adverse effects from the usage of the product.

Sildenafil

Sildenafil is typically used for the treatment of erectile dysfunction, but it can also be prescribed to help adults with pulmonary arterial hypertension (PAH) with their ability to exercise. It helps people with erectile dysfunction by increasing blood flow to the penis, and it helps people with PAH by relaxing the blood vessels so that blood will flow to the lungs easily.

Some side effects of sildenafil may include dizziness, headache, heartburn, diarrhea, muscle aches, changes in color vision, sensitivity to light, and difficulty sleeping or staying asleep. It is important to contact the doctor if these symptoms are severe or do not go away. This is especially important to remember for the more serious side effects such as blurred or loss of vision, chest pain, rash, loss of hearing, and shortness of breath.