Product Liability

Sexual enhancer found to contain potentially dangerous ingredient

The Food and Drug Administration (FDA) is warning consumers not to use a sexual enhancement capsule distributed by Natural Wellness because the product contains an undeclared ingredient that may cause serious, life-threatening conditions for some populations.

MasXtreme Capsules, sold in blister packs containing one capsule and distributed nationwide, have been found to contain the ingredient aildenafil which is close in structure to sildenafil and likely possesses a similar pharmacological and adverse event profile. The dietary supplement also was found to contain the drug phentolamine, an alpha-adrenergic blocker.

Aildenafil 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 dangers levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and are at increased risk of adverse events if they take MasXtreme.

Phentolamine is a drug used to control hypertensive emergencies and is used in particular for the treatment of cocaine-induced hypertension. Common side effects of phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heartbeat).

Consumers who have purchased MasXtreme capsules are urged to immediately discontinue use of the product and return them to the place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, Fla., 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 p.m.

Those who have had medical issues following use of the drug should contact their health care professional. Any adverse events to this or any other product should be reported to the FDA MedWatch Safety Information and Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.