FDA issues consumer update on dietary supplements marketed for erectile dysfunction

FDA issues consumer update on dietary supplements marketed for erectile dysfunction

​Prescription erectile dysfunction (ED) drugs are big business. In 2013, of the top nine prescriptions drugs for which the most money was spent on direct-to-consumer (DTC) advertising, leading the league was Cialis, with Viagra coming in third. Lilly spent $210 million on Cialis DTC ads, while Pfizer spent just over $150 million on Viagra. 

Where there is money to be made, dietary supplement manufacturers are all over it. Unfortunately, unlike men taking Cialis and Viagra, those choosing dietary supplements to treat ED have no physician intermediary to determine what treatment is best, no detailed product information, no premarket FDA approval process, no list of side effects or possible drug interactions. Just a label, which may (or may not) disclose the ingredients and tell the buyer that the FDA has not vetted the claims the seller is making, if that.  

Because there is no premarket approval process for dietary supplements, the FDA has to play catch up. And that's what the agency has been doing with dietary supplements marketed for ED.  It's findings are disturbing

FDA lab tests found that nearly 300 of dietary supplements marketed for ED contain undisclosed drug ingredients.Three hundred! Those and, presumably, more that weren't tested, as opposed to 3 prescription drugs: Viagra, Cialis and Levitra. That's what pre-market regulation will do for you: Winnow out the losers, leaving only those products proven safe and effective. But, guess what some of these "natural" dietary supplements contained? Viagra, Cialis and Levitra. Not only that, sometimes these products include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations.

For example, one of the tainted products included 31 times the prescription dose of tadalafil (the active ingredient in Cialis), in combination with dapoxetine, an antidepressant that is not approved by FDA. I don't even want to think about what may have happened to the poor man who took that dietary supplement.

Are these drug ingredients listed on the label? Of course not. Nor are the warnings that would accompany the real drug, even though there may be serious consequences when combined with other drugs the consumer is taking.  As the FDA notes,  "for example, taking a product that contains sildenafil (the active ingredient in Viagra) in addition to certain 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 those conditions commonly suffer from erectile dysfunction."

And these products are everywhere. They're sold online, in retail stores, and in single-serving sizes in gas stations and vending machines, as pills, coffees, chewing gum and dissolvable oral strips. 

A sensible solution, of course, would be discard the myth that dietary supplements aren't drugs. They should be treated like any other over-the-counter drug and required to show they are safe and effective before they are put on the market. They should have to give the consumer adequate information about the possibility of interactions with other products and potential side effects. Unfortunately, as long as the "health freedom" lobby and paid benefactors like Sen. Orrin Hatch are around, that is unlikely to happen. 

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