FDA says men should put down the Man Up
by Aimee Keenan-Greene
The U.S. Food and Drug Administration says stop using a dietary supplement marketed for sexual enhancement.
Man Up Now claims to be 'herbal' and 'all natural', which may lead consumers to mistakenly assume the product is harmless and poses no health risk.
The FDA says Man Up Now contains a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure. Sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra - may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure, depriving the brain of an adequate blood supply.
Sexual enhancement products that claim to work as well as prescription products, but that contain prescription strength drugs, are likely to expose unknowing consumers to unpredictable risks and the potential for injury or death.
In the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement potentially harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients.
Working with other FDA components, the division's Internet and Health Fraud Team led an Internet survey in which more than one-third of purchased "dietary supplements" claiming to spur sexual enhancement or treat Erectile dysfunction, contained undisclosed prescription drug ingredients or similar substances.
Six of the 17 products contained sildenafil - the active ingredient in Viagra, or a substance similar to either sildenafil or vardenafil. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.
Mark Hirsch, a medical team Leader in CDER's Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.
"These products may interact in dangerous ways with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.
People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates, and men with these conditions commonly suffer from ED, Hirsch says. "Those are factors that doctors consider when prescribing approved ED treatments."
So far there are no reports of injury associated with Man Up Now. The FDA advises consumers who have experienced any negative side effects from any sexual enhancement products to see their doctor.