RegenArouse (When Supplements Work?)

Real drugs, with real physiological activities, have very real side effects. As a result, some drugs cannot be safely taken by some individuals with underlying conditions or who are taking other, incompatible medications. When “nutritional supplements” contain undisclosed drugs, potentially dangerous side effects and interactions cannot be avoided.  Individuals that cannot take a drug due to underlying risk factors may be more likely to be customers for these alternative treatments, placing them at even greater risk. To err is human. To have an undeclared drug in your supplement that happens to cause the same therapeutic effects claimed for your supplement is anything but divine.

The latest supplement to run afoul of the FDA’s “if you product contains a drug, it is a drug” rule is RegenArouse, a supplement for erectile disfunction, which was found to contain tadalafil.

Regeneca, Inc. notifed the public of a nationwide recall of RegenArouse, Lot Number 130100. FDA lab analysis confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product unapproved new drug.

Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance

FDA MedWatch

Author: Josh Witten

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