Viagra 007 Raises FDA Red Flags.
Posted by: Don Amerman in Viagra June 29, 2015 Comments Off on Viagra 007 Raises FDA Red Flags 4,371 Views.
Unlike prescription drugs, dietary supplements are not subjected to stringent testing before they can be marketed to consumers.
Viagra 007 is a cleverly named dietary supplement being aggressively marketed as a less expensive alternative to Viagra, the popular impotence medication. That it might produce positive results for some of its users probably should not come as much of a surprise since it turns out that one of its undeclared ingredients is sildenafil citrate, the active ingredient in the little blue pill that revolutionized the treatment of erection problems.
You might ask, So what’s the big deal? Well, the folks at the U.S. Food and Drug Administration think it’s a very big deal indeed. So much so that on April 30, 2015, the agency issued a medication health fraud alert, advising consumers not to buy or use Viagra 007. The FDA indicated that the secret ingredient had been discovered by FDA during an examination of international mail shipments.
Supplement Could Endanger Some.
Some of the men most likely to be attracted to Viagra alternatives might well be those who should not be taking sildenafil or any of its closely related PDE5 inhibitor cousins because of pre-existing medical conditions or the danger of drug interactions.
With no mention of sildenafil on Viagra 007’s product label, unsuspecting consumers could very well buy the supplement thinking they are buying a product that can help them recover erectile function without exposing them to the dangers the PDE5 inhibitors can cause.
For example, men who take nitrate-based drugs to help relieve the chest pain of angina pectoris are instructed to avoid Viagra and all other PDE5 inhibitors because both nitrates and PDE5 inhibitors sharply lower blood pressure. Taken together, they could cause such a precipitous decline in blood pressure as to be life threatening.
Other Users of Nitrates.
Although angina patients are perhaps the single largest group of health consumers routinely using nitrates, patients with high blood pressure, diabetes, elevated blood cholesterol levels, and heart disease may also take nitrates. Recreational drugs known as “poppers” also contain high levels of nitrates and thus should never be used at the same time as PDE5 inhibitors, such as Viagra.
In a statement accompanying its warning about Viagra 007, the FDA noted that the dietary supplement is yet another example of “a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.”
Frustrated and desperate to find a solution, men with erection problems are sometimes to try products that may have unintended side effects and consequences.
The watchdog agency went on to say that these products are generally promoted as “all natural” and are specifically targeted at consumers interested in body building, weight loss, and/or sexual enhancement.
Supplement from China.
Viagra 007 is manufactured and marketed by Guangzhou Way Well Health Products Ltd. of China. In its online promotional materials for the product, the company acknowledges that despite its great popularity, the drug Viagra isn’t a viable option for men “with certain cardiovascular problems” and may also be avoided by others wary of its side effects.
The Chinese company’s promotional literature then goes on to tout Viagra 007 as an alternative that “contains a proprietary formula designed to improve the quality of men’s erections.” It also notes that Viagra 007 pills contain “proven high expansion vasodilators that can promote healthy erectile function.” However, while touting Viagra 007 as a safe alternative to the real thing, nowhere does its manufacturer disclose that one of those vasodilators is sildenafil, Viagra’s active ingredient.
One online advertisement for Viagra 007 listed its main ingredients as follows: Crocuses, aweto, snow lotus, Tibetan yak testicles, seahorse, velvet, and ginseng. According to Merriam-Webster.com, aweto is “the mummified body of a caterpillar killed by the attack of a parasitic ascomycetous fungus ( Cordyceps robustus ) together with the elongated fruiting body of the fungus which projects from the neck of the mummy.” Sound like something you’d like to put in your body? I thought not.
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Similar Warning in 2014.
The FDA warning about Viagra 007 came almost a year after a similar alert in June 2014. In that case, the federal agency warned consumers to steer clear of a dietary supplement with the provocative name of Dick’s Hard Up. Like Viagra 007, Dick’s Hard Up was at the time being promoted for its powers of “male enhancement.”
In that case, FDA announced that the dietary supplement contained undeclared and unspecified quantities of tadalafil, the active ingredient in Cialis, another of the popular PDE5 inhibitors sold primarily to allow impotent men to temporarily recover erectile function. FDA’s warning to consumers was based on the same grounds as its alert in the Viagra 007 case, namely that Dick’s Hard Up could potentially harm consumers unaware that the supplement contained the active compound of a PDE5 inhibiting drug.
Viagra 007 Still Available.
A cursory Internet check for both Viagra 007 and Dick’s Hard Up indicates plenty of Web offers for the former and little or nothing about the latter, which FDA warned against in June 2014. Hopefully, the agency’s alert about Dick’s Hard Up helped to dry up whatever market might have existed for the product, but at least for now (early June 2015), Viagra 007 is still available to consumers.
Although the U.S. Food and Drug Administration doesn’t routinely test dietary supplements, it tries to alert the public if it becomes aware that a supplement contains undeclared or potentially toxic ingredients.
While both these cases attracted widespread attention and publicity, FDA posts scores of such alerts annually just in the lone category of Tainted Sexual Enhancement Products, which is only one segment of the vast dietary supplements market. It also does its very best to police other segments of the dietary supplement market as well.
Many Supplements Go Untested.
But, as the agency itself points out, it can’t test every product on the market that might potentially contain harmful hidden ingredients. “Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”
With federal budgets for most agencies shrinking, FDA and other government agencies must make do with less. For that reason, FDA has established a mechanism that allows consumers and others to call the agency’s attention to dietary supplements of questionable value. Obviously, the average consumer has no way of testing a product’s ingredients to see what, if any, undeclared substances might have been used in producing the supplement.
But all consumers have ways of recognizing when something just isn’t right about a product they are using. Does the product produce side effects that are extremely unpleasant and that somehow escaped mention in the product’s informational label or accompanying literature? Does the product fail to deliver on its primary promise? As in weight loss supplements that fail to help you shed pounds or an “all-natural” PDE5 inhibitor alternative that does nothing to help you get and keep an erection?
Notifying the FDA of such defects in product quality or safety won’t get you back the money you spent to buy the product, but it could help keep others from falling victim to the same scam, if indeed the product is a scam. If you have genuine concerns about a dietary supplement’s quality and/or safety, you can visit the government’s Safety Reporting Portal and report the issue.
While this article concerns itself specifically with dietary supplements, particularly those that claim to help overcome erection problems, the Safety Reporting Portal can be used to advise the FDA of safety concerns about other products as well. Such products include animal foods and drugs, human drug and therapeutic biologics, human foods, and tobacco products.
At the risk of restating the obvious, buyers who are considering buying a new, highly-touted dietary supplement either online or in a retail shop should first check FDA’s website to see if the agency has had anything to say about the supplement.
And even if the supplement in question has escaped the agency’s attention up to that point, you might consider confining your purchases to supplements manufactured and marketed by companies that are recognized as reliable suppliers of such products.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.