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Another erectile dysfunction (ED) product marketed as a “dietary supplement” has been recalled. The U.S. Food and Drug Administration (FDA) recently informed Intelli Health Products, the makers of Duro Extend, that the supplement contained Sulfoaidenafil. That ingredient is an analogue of Sildenafil, which is the FDA-approved active ingredient in Viagra.
Intelli Health Products recalled only a certain amount of Duro Extend in late October – 12 lot numbers to be exact. However, the company announced this week that all lot numbers are recalled.
The FDA has warned consumers to stop using Duro Extend (and return the product for a refund) if they have the product in their possession. This is because Sulfoaidenafil can cause a severe drop in blood pressure, which can cause a stroke or even death, if taken with any medications that contain nitrates.
Nitrates are often prescribed to treat conditions such as diabetes, high blood pressure, high cholesterol and heart disease. Men with these conditions often have ED, so this makes them prime candidates to seek out “alternative” ED options in place of the more expensive brand-name options of Viagra, Cialis and Levitra.
What’s truly amazing about the Duro Extend recall is the statement released by Intelli Health Products. The company says on its press releases that it “conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Sulfoaidenafil but Intelli Health Products assures consumers that this deficiency is being rectified.”
This statement begs the question… what exactly is Intelli Health Products testing for? The company makes it sound as if it has no idea how Sulfoaidenafil ended up in its products, and no explanation is given. It seems to this author that the company had to have prior knowledge of the fact Sulfoaidenafil was in Duro Extend. Either way, this should be quite worrisome to consumers, especially considering the high number of “natural” ED products and “dietary supplements” that have been recalled by the FDA. Not to mention the lives that Intelli Health and others may have put in danger.
eDrugstore reported last month that the FDA banned Vigor-25 after it was found to contain sildenafil, and to potentially have caused the death of a 26-year-old man. An investigation into that matter is still ongoing.
The FDA has banned/forced recalls on more than a dozen “dietary supplements” that have professed to naturally help men perform better in bed. At face value, these rather inexpensive pills seem like a bargain worth trying out. However, considering the numerous FDA recalls on these products, men are taking serious health risks.
The dietary supplement industry is largely unregulated by the FDA because the products are not considered to be drugs. The FDA typically only steps in if there are a bothersome number of adverse events associated with a supplement.
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