The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. public health at risk,” Donald Ashley, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in the FDA's statement.For more medication health fraud topics, please see our Medication Health Fraud page.įDA is notifying consumers of certain products promoted for sexual enhancement that have been found to contain hidden ingredients and may pose a significant health risk. Distributing unapproved drugs, disguised as supplements, places the U.S.

“Over the past few years, the FDA has been combatting the retail sale of male enhancement drug products that are frequently misrepresented as dietary supplements and that contain hidden and potentially harmful active drug ingredients. McElwee suffered from a drop in blood pressure that led to a fatal heart attack two days after taking a male sexual enhancement product sold under the name Stiff Nights, according to the Star. In 2012, a 39-year-old man in Kansas died after taking an unapproved erectile dysfunction drug allegedly labeled as a supplement, the Kansas City Star reported. For example, they may interact with other prescription drugs containing nitrates, which are often taken by people with diabetes or heart disease, and lower blood pressure to dangerous levels, the agency wrote. These undeclared active ingredients can cause side effects or serious adverse reactions. While these two drugs are FDA-approved to treat erectile dysfunction, they have to be prescribed by a doctor - and they do not belong in over-the-counter supplements. 'The FDA has identified various Rhino products containing sildenafil and/or tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively,' the agency wrote. The Rhino products are one example of many sexual enhancement supplements containing unapproved, hidden ingredients that are the same as or chemically similar to the active ingredients in prescription medication. The supplements are not FDA-approved to treat male sexual dysfunction, despite the claims made on their packaging. The products are sold under a variety of names that include Rhino, such as Platinum Rhino 25000 or Krazzy Rhino 25000. People who took Rhino products reported chest pain, severe headaches, prolonged erections - sometimes requiring surgical intervention - and even hospitalization due to extreme drops in blood pressure, the agency said. The FDA urged people this week not to buy or use Rhino male enhancement products because they may contain dangerous, hidden ingredients.

Largely unregulated, these supplements can come with hidden health risks - and one brand in particular has come under fire recently for its potentially harmful contaminants. They're usually sold at gas stations or convenience stores, and increasingly on e-commerce websites. You've probably seen these before - over-the-counter sexual enhancement supplements with bizarre names and packaging, promising everything from a bigger penis to increased stamina.

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