Today, the FDA issued yet another health warning regarding an unapproved sexual enhancement product marketed as an over-the-counter drug and, boy, is this one a doozy. It contains sildenafil and tadalafil, the active ingredients in approved Viagra and Cialis, while also containing, flibanserin, which “is the active ingredient in Addyi, an FDA-approved prescription drug used to treat low sexual desire in women.” This is the absolute trifecta of unapproved active ingredients for sexual enhancement products—for both genders at once!
The FDA states, “[t]his notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals.” Sildenafil and tadalafil are prescription ingredients that can cause dangerous hypotension if taken with certain nitrates like nitroglycerine. Flibanserin can cause drowsiness and sedation and, according to the notice, “[i]t also can cause dangerously low blood pressure and fainting, especially when combined with alcohol.” All three of these undeclared components can cause serious adverse events when taken with other prescription drug products. This product is perhaps not the best (and may be the worst) dietary supplement to pick up at the gas station or minimart!
The product is called WAP. I’ve avoided inclusion of the label from the FDA website as it uses some very colorful and inappropriate language. The full FDA notice can be found here but beware—the label’s language may not be appropriate for all audiences and may be offensive to others. So, best advice, just take my word for it and warn others about its dangers.
To answer the question posed in the title to this post, the FDA continues to utilize its resources, when available, to keep dangerous unapproved drugs, masquerading as dietary supplements or foods, from entering U.S. commerce. But as the number of these notices seems to be increasing, the crooks clearly outnumber the good guys!
