U.S. FDA Issues Warning and Orders Drug Recall of Male Enhancement Pills Sold on Amazon
Nikhil Prasad Fact checked by:Thailand Medical News Team Dec 10, 2024 1 day, 15 hours ago
U.S. Medical News: The U.S. Food and Drug Administration (FDA) has issued a dire warning and announced a recall of four male enhancement products sold online via Amazon. These pills, marketed as dietary supplements, are now classified as high-risk under a Class I recall - the FDA’s most serious alert category as of the 2
nd of December 2024.The government agency warns that using these products could lead to life-threatening health complications.
https://www.accessdata.fda.gov/scripts/ires/?Event=95714
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boulla-llc-issues-voluntary-nationwide-recall-zoommax-and-zapmax-capsules-due-presence-undeclared
U.S. FDA Issues Warning and Orders Drug Recall of Male Enhancement Pills Sold on Amazon
The products in question - ZoomMax Capsules and ZapMax Capsules by Boulla LLC, as well as VitalityXtra Capsules and PeakMax Capsules by VitalityVita - were found to contain undeclared pharmaceutical ingredients. These ingredients include sildenafil, a prescription drug for erectile dysfunction, and diclofenac, a powerful anti-inflammatory medication. The presence of these drugs makes the supplements illegal for sale as dietary products. This
U.S. Medical News report sheds light on the risks involved and the steps you can take to protect yourself.
What Makes These Pills So Dangerous?
According to the FDA, sildenafil can dangerously lower blood pressure, especially in individuals taking medications that contain nitrates. Nitrates are commonly prescribed for conditions such as diabetes, high blood pressure, high cholesterol, or heart disease. The agency cautioned that men who use these pills while on nitrate therapy face a significantly heightened risk of health complications.
Diclofenac, the other undeclared ingredient, carries its own set of dangers. This NSAID is associated with increased risks of cardiovascular events like heart attacks and strokes. Additionally, it can cause serious gastrointestinal damage, including bleeding and ulcers. For consumers who unknowingly ingest these hidden ingredients, the risks can multiply if they are taking other NSAID-containing medications. Such interactions may lead to severe health outcomes.
Who Is at Risk?
These male enhancement products are most commonly used by adult men seeking quick fixes for sexual performance issues. However, individuals with pre-existing conditions such as diabetes, hypertension, or heart disease are particularly vulnerable to the adverse effects. Given the growing popularity of online shopping, many consumers purchase these products without consulting healthcare professionals, putting themselves at unnecessary risk.
The recalled products were packaged in 10-count blis
ter packs with the following details:
ZoomMax Capsules and ZapMax Capsules: Lot code YZM240406, expiry date April 5, 2027.
VitalityXtra Capsules and PeakMax Capsules: Lot code 230811, expiry date August 11, 2025.
Although no adverse effects have been reported to the companies at the time of the recall, the FDA warns that the lack of immediate reports does not mean the products are safe.
A Growing Problem in the Supplement Market
The male enhancement supplement market is booming, with projections estimating its value at US$1.03 billion by 2028. This surge in demand is partly driven by the convenience of e-commerce platforms like Amazon. However, as the FDA has repeatedly pointed out, buying medications online comes with significant risks. A 2020 FDA report revealed that 80% of male enhancement and weight loss supplements purchased on platforms like Amazon and eBay contained undeclared pharmaceutical ingredients.
These findings raise concerns about the regulation of dietary supplements sold online. Despite being marketed as “natural,” many products are laced with prescription drugs, posing hidden dangers to unsuspecting consumers.
What Should Consumers Do?
If you have purchased any of the recalled products, the FDA advises you to stop using them immediately and consult a healthcare professional, especially if you are experiencing any symptoms or are on other medications. You can return the products to the place of purchase for a refund.
Additionally, consumers should exercise caution when purchasing dietary supplements online. Always read product labels carefully and look for any unusual claims, such as “fast-acting” or “pharmaceutical-grade.” For safety, consult a licensed healthcare provider before starting any new supplement regimen.
The Importance of Medical Oversight
While many individuals may feel hesitant to discuss sexual health issues with their doctor, having an open and honest conversation with a healthcare professional can be a safer and more effective way to address concerns. Licensed medical practitioners can recommend approved treatments and guide you toward safe options.
This incident underscores the need for greater awareness among consumers about the risks of self-medicating with unverified supplements. As the FDA’s findings demonstrate, the lack of oversight in the online supplement market can have dangerous consequences.
Concluding Thoughts
The FDA’s recall of male enhancement pills sold on Amazon serves as a stark reminder of the risks associated with unregulated dietary supplements. Products like ZoomMax, ZapMax, VitalityXtra, and PeakMax Capsules may seem harmless on the surface, but their undeclared ingredients can pose severe health threats, especially to vulnerable populations. As consumers, it’s vital to stay informed and make decisions based on reliable information. Trusting unverified online products over medical advice is a gamble no one should take.
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