Nationwide Recall of MasXtreme Due to Undeclared Drug Ingredients


March 31, 2010

Nationwide Recall of MasXtreme Due to Undeclared Drug Ingredients

MasXtreme recalledMasXtreme is a dietary supplement marketed for increasing desire and sexual performance. This product is made by Natural Wellness Inc. The manufacturer and the FDA have notified consumers that these capsules contain an undeclared drug ingredient known as aildenafil. This drug is similar to sildenafil which is an FDA approved treatment for erectile dysfunction and can be expected to produce the same adverse event profile and pharmacological profile. These capsules also contain an alpha-adrenergic blocker, the drug phentolamine.

While many people may have no problem with these drug ingredients Natural Wellness has voluntarily recalled MasXtreme capsules nationwide for the benefit of all consumers such as those who take nitroglycerin, and other nitrate prescriptions. When aildenafil interacts with nitrate prescriptions blood pressure could drop dangerously low. The patients who need to be informed of this are consumers who have diabetes, high blood pressure, heart disease or high cholesterol.

Phentolamine produces several common side effects that can be dangerous with or without the presence of nitrates. These include arrhythmia and tachycardia, otherwise known as an abnormal heart rhythm and rapid heartbeat respectively. The presence of nitrates increases the risk of serious health problems. Whether you are on nitrate prescriptions or not, it is important to adhere to this recall and discontinue use and purchase of this product.

Natural Wellness Inc. has distributed the MasXtreme blister packs nationwide. Anyone who has purchased these capsules is urged to discontinue use immediately. Details about this voluntary nationwide recall can be found on the FDA website in a press release issued by Natural Wellness Inc.

The FDA’s MedWatch reporting program is taking calls and online reports of adverse events and reactions experienced by consumers of MasXtreme. To make a report visit www.fda.gov/MedWatch.report.htm or call 1-800-332-1088.

Publisher: Salient News