The FDA and Natural Wellness have issued a voluntary nationwide recall of MasXtreme capsules which are being marked as a dietary supplement for increasing desire and sexual performance. MasXtreme contains undeclared amounts of aildenafil, which is close in structure to sildenafil, an FDA-approved drug used to treat erectile dysfunction. This may pose a threat to consumers because aildenafil may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, hypertension, hypercholesterolemia, or heart disease often take nitrates. MasXtreme also contains undeclared phentolamine, an alpha-adrenergic blocker. Common side effects of phentolamine include arrhythmia and tachycardia.
Consumers who have MasXtreme capsules in their possession should stop using them immediately and contact their healthcare provider with any questions or concerns.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206791.htm.