MasXtreme Supplement Recalled Due to Possible Drug Interaction Dangers

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Natural Wellness Inc. of Deerfield Beach, Florida, is cooperating with the Food and Drug Administration on the recall of its sexual performance enhancement dietary supplement product MasXtreme. The product contains an undeclared amount of one drug-like compound and has another ingredient that could be dangerous when combined with certain prescription drugs.

MasXtreme is sold in blister packs containing one capsule. It is considered a dietary supplement, and does not require a prescription. The recall specifically involves Lot #911035.

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The FDA has found that MasXtreme contains aildenafil, which is similar in structure to sildenafil used in the prescription medication Viagra to treat erectile dysfunction. The ingredient could cause negative reactions in patients taking nitrates such as Nitro-Dur, Nitrostat, Imdur, or Isordil. It can also cause a sudden decrease in blood pressure.

The second problematic ingredient is an alpha-adrenergic blocker called phentolamine, used to prevent or control hypertensive episodes. Phentolamine can cause arrhythmia (abnormal heart rhythm) and tachycardia (rapid heartbeat), as well as dizziness, weakness, orthostatic hypotension (low blood pressure upon standing), nausea and vomiting.

Consumers using the supplement products should discontinue use immediately. Anyone experiencing adverse effects after using the supplement should immediately contact their personal healthcare providers and report the concern to the FDA’s MedWatch program.

Natural Wellness will accept returns of the supplement at 440 S. Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions may also call 954-570-6662, Monday through Friday, 8am to 4pm.

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