MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient
Audience: Consumers, Pharmacists
Natural Wellness and FDA notified consumers that MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil 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. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).
MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use.
Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.accessdata.fda.gov/scripts/medwatch/index.cfm1], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]
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