For the second time in two weeks, the U.S. Food and Drug Administration (FDA) has warned men not to use an erectile dysfunction supplement that was billed by the manufacturer to be “all-natural.” In both cases, the FDA discovered that the pills actually contained Sulfoaildenafil, which is a chemical similar in composition to Sildenafil, the main active ingredient in FDA-approved Viagra.
Although an official recall of the product has yet to be issued by Synergy Distribution, the FDA will not ultimately allow the company to distribute Man Up Now that contains an analogue of Sildenafil. Last week, Intelli Health Products announced a recall for all lots of its Duro Extend ED product, after it was found to also contain Sulfoaildenafil.
As of this afternoon, Man Up Now was still available on the www.a1supplements.com website at a cost of $9.75 for three pills.
The FDA has warned against using Man Up Now because “herbal” or “natural” ingredients that actually contain prescription-strength drugs “are likely to expose unknowing consumers to unpredictable risks and the potential for injury or death.”
In this case, Sulfoaildenafil can pose a serious health risk to patients who take nitrates or alpha blockers due to a serious drop in blood pressure. The brain does not receive an adequate supply of blood when blood pressure drops suddenly, and this can lead to dizziness, lightheadedness, stroke or worse.
Every time a doctor prescribes a prescription medication, they take into account all other medications that a person is taking. This is why it is important for patients not to put their health at risk by either ordering ED “supplements” or “herbal” remedies online, or by ingesting prescription medications that came from friends or acquaintances.
In its press release that warns men to not use Man Up Now and similar products, the agency told consumers to be aware of products that make false promises. Many times, these types of products are dead giveaways because they are marketed as “sexual enhancement” products that will improve just about every aspect of a man’s sexual performance.
If a product promises that it works in minutes, or quickly provides effects for 24 hours to 72 hours, the FDA says, it likely contains ingredients (or variations of ingredients) that are legal only in FDA-approved medications. Always remember the saying, “You get what you pay for.” Not only do most ED “supplements” not provide the results men want, men are often unknowingly ingesting harmful and unknown substances. It’s simply not worth the risk.
Viagra, Cialis and Levitra work in specific ways as PDE-5 inhibitors to relax the muscles in the penis so that blood vessels become full and cause an erection. These erectile medications are proven to provide results in clinical studies, as required by the FDA. Supplements are not regulated by the FDA, and the FDA is hands-off unless it receives complaints about these products – or in this case, unless it samples one of many ED supplements it believes is most likely illegal.
To date, the FDA has banned/provided warnings for about three dozen ED “natural” or “herbal” supplements. As evidenced by two recent warnings this week (Man Up Now) and last week (Duro Extend), there are likely many more illegal and potentially harmful products that are still on the market.
Here’s a list of ED “supplements” that have received warnings from the FDA, as well as the FDA’s official stance regarding ED “supplements.” And here’s the FDA’s complete warning about Man Up Now (and similar products).
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