The U.S. Food and Drug Administration (FDA) halted production of Vigor-25 and warned consumers that it could be harmful to their health. The drug, which was marketed as an “all-natural” supplement for erectile and sexual dysfunction, is being investigated by the FDA in relation to the death of a 26-year-old man.
Vigor-25 was available on Amazon.com and other websites such as eVitamins.com until the FDA recall. Three of the pills had been on sale for less than $13 on eVitamins.com. Piston Corp. was the manufacturer of the drug.
An FDA spokesperson stated that “tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions.”
Natural supplements are loosely regulated by the FDA, and they are not often tested unless there are numerous consumer complaints – or in this case, a reported consumer death that could be associated with the “supplement.”
The FDA issued the recall for Vigor-25 because it is falsely advertised and contains an active ingredient (sildenafil, the active ingredient in Viagra) that could cause an interaction with other medications such as nitrates or alpha blockers. Sildenafil can cause a sudden, harmful drop in blood pressure if taken with these other medications.
The FDA has stopped the production of numerous “natural” products marketed as “supplements” for sexual enhancement. All of the drugs, including Stiff Nights, Energy Max, Super Shanghai and others, were found to contain potentially harmful active ingredients. The danger for consumers lies not only in the fact that the products are mislabeled with regard to their ingredients, but also due to the fact there are unknown quantities of ingredients in the unregulated pills.
It is very important for consumers to purchase their medications and supplements from trusted U.S. companies – especially when they buy medications online.
Many websites that sell medications online are based in foreign countries, and both their medications and operations are not regulated in any way. These websites, for instance, sell “generic” Viagra that could be harmful to a person’s health. First off, these medications are illegal in the U.S. and are in violation of Pfizer’s patent for Viagra (which lasts until March 27, 2012.) Secondly, these medications could contain too little, too much, or no active ingredient at all. And lastly, the medications often contain filler ingredients that could include things such as paint or guano.
It seems that the FDA is cracking down on an illegally distributed “supplement” for erectile dysfunction or sexual enhancement every month. This should lead consumers to be wary of these supplements. Although the price of the supplements may be attractive, what’s inside the actual pills can be anyone’s guess. Therefore, instead of taking a chance on whether the pills will be safe and/or effective, it’s best to leave nothing to chance and purchase FDA-approved medications such as Viagra, Cialis and Levitra. These medications were proven to be safe and effective by the FDA (and any side effects, usually minor, have been documented.)
For more information on the FDA’s comprehensive approval process for medications, see the FDA website.
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