Much to the chagrin of industrious and compassionate healthcare providers, the world is rife with fraudulent drug products of dubious efficacy, which tout the treatment of disease or enhancement of health. Not only do these sham supplements dupe hard-working Americans out of billions of dollars, but they can lead to serious and even deadly outcomes. Fortunately, the FDA is on the case, working to expunge the market of these products. The FDA publishes a database of tainted products marketed as dietary supplements. This resource, however, addresses only a fraction of potentially hazardous products with hidden and potentially dangerous ingredients. The FDA lacks the resources to test and identify all of these supplements—consequently, even if a product is unlisted, it could still exact health risks, and caution should always be taken when in doubt. In a recent news release, the FDA warned of nearly 50 male-enhancement and weight-loss products that are sold online and in some retail stores that ran afoul of its guidance. These products contain hidden ingredients and pose a risk to the public. Let’s take a closer look at the FDA’s concerns, as well as examples. Testing The FDA purchased health-enhancement or weight-loss products of concern on eBay and Amazon for laboratory testing. The FDA investigation revealed that they were laced with active pharmaceutical ingredients not listed on the labels—including some found in prescription drugs. Such chemical constituents can cause serious adverse effects, as well as drug-drug interactions either with prescription drugs or other supplements. Specifically, 26 of 26 products the FDA purchased on Amazon and 20 of 25 products procured on eBay consisted of undeclared active pharmaceutical ingredients. These products included desmethylsibutramine, fluoxetine, sibutramine, phenolphthalein, sildenafil, tadalafil, and vardenafil. According to the FDA release, “Many of the products the agency purchased from Amazon and eBay have names that are the same as, or similar to, tainted products that have been the subject of previous FDA consumer warnings. Several of the Amazon products are designated as an ‘Amazon Choice’ or ‘#1 Best Seller.’” They added, “Products with undeclared drug ingredients violate federal law. In general, these products are unapproved new drugs and/or adulterated dietary supplements. In addition, they are misbranded because their labels do not accurately reflect their ingredients.” Dangerous male-enhancement products Here are some examples of male-enhancement products that the FDA has decried, including some from its most recent battery of testing. White Panther. This product contains sildenafil and tadalafil (the active ingredients in prescription medications such as Viagra and Cialis, which are FDA-approved to treat erectile dysfunction.) Of concern, the phosphodiesterase-5 (PDE5) inhibitors contained herein interact with nitrates found in some prescription drugs such as nitroglycerin, thus potentially causing blood pressures to bottom out. This is of special concern for those with diabetes, high blood pressure, high cholesterol, or heart disease, who often take nitrates. Triple Wicked Platinum. This product also contains sildenafil and tadalafil. Thumbs Up 7 White 11K. In addition to sildenafil and tadalafil, this product contains vardenafil—the active ingredient in Levitra, also used to treat erectile dysfunction. Power Khan. This product contains desmethyl thiosildenafil, thiosildenafil, and aildenafil, which are all PDE5 inhibitors similar to sildenafil, and may cause a dangerous drop in blood pressure when interacting with nitrates. Man Fuel Xtreme Edition. This product contains sildenafil, dithiodesmethyl carbodenafil, and desmethyl carbodenafil—the latter two of which are similar in structure sildenafil. Dangerous weight-loss products Like the aforementioned male-enhancement drugs, the following smattering of weight-loss aids have also been cited over the years by the FDA for similar adulterants. Super Slim. This product contains sibutramine and desmethylsibutramine. Sibutramine is a controlled substance that was yanked from the market in October 2010 for safety reasons. Desmethylsibutramine is chemically similar to sibutramine. According to the FDA, sibutramine increases blood pressure or heart rate in some users and is of particular concern in those with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This active ingredient also poses the risk of dangerous drug-drug interactions. Body Shape Weight Loss System. This product contains sibutramine. Lishou Slimming Coffee. This beverage contains sibutramine and desmethylsibutramine. Livtone. This product contains sibutramine and fluoxetine—a selective serotonin reuptake inhibitor (SSRI). Adverse effects of fluoxetine include suicidal ideation, seizures, and abnormal bleeding. Additionally, it can cause drug-drug interactions with nonsteroidal anti-inflammatory drugs (NSAIDs), other psychotropics, heart medications, chemotherapy drugs, and more, thus potentially resulting in ventricular arrhythmia and death. Ultimate Boost. This product contains phenolphthalein, an unapproved active ingredient that is also a carcinogen. Because eBay and Amazon are complicit in bringing these potentially dangerous supplements to market, the FDA engaged these corporate behemoths. “Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant and communicate about products and companies that place U.S. consumers at risk,” said Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in the aforementioned press release. He added, “While the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past, we believe they can do more to protect consumers from these fraudulent and potentially dangerous products. We continue to urge stores, websites and online marketplaces, like Amazon and eBay, to take appropriate steps to protect the American public by not selling or facilitating the sale of illegal FDA-regulated products.” The FDA encourages healthcare professionals as well as consumers to report any adverse events to its MedWatch medical safety reporting program. Source
