Arouse-Plus, a dietary supplement sold as a sexual enhancement treatment, should not be purchased or used because it contains a hidden drug ingredient that may pose health risks to some consumers, the Food and Drug Administration (FDA) warned in a public notification. The product is marketed for men.
Through laboratory analysis, the FDA confirmed that Arouse-Plus contained tadalafil, the active drug ingredient in the prescription erectile dysfunction drug Cialis. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and could lower blood pressure to dangerous levels. Men who have diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Anyone who has taken this product and suffered from any side effects should consult with their doctor, seeking medical attention if symptoms are serious. Any adverse events related to use of this products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
The FDA’s public notice regarding Arouse-Plus is yet another example of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals that pose a risk to public health. The products are typically promoted for sexual enhancement, weight loss, and body building or athletic performance. They are also often represented as “all natural.”
The FDA cautions that it cannot test and identify all products marketed as dietary products that have potentially harmful ingredients, thus consumers should exercise caution before purchasing any dietary supplement, especially those for sexual enhancement, weight loss, or athletic performance.