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FDA recalls Stamina-Rx Dietary Supplement products due to inclusion of an undeclared and unapproved drug, benzamidenafil, which can cause severe low blood pressure.
Press release
The FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx.
FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction.
Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in their possession should stop using it immediately.
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Image: Newscom.com
