The U.S. Food and Drug Administration (FDA) is warning consumers about the dangers posed by sexual enhancement and "natural" erectile dysfunction drugs.
MasXtreme, a dietary supplement, is sold without a doctor's prescription, but the FDA says it shouldn't be.
Natural Wellness, maker of the tablets, is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA has determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil.
Tadalafil is an FDA-approved drug used to treat erectile dysfunction (ED), making the MasXtreme, in the eyes of the FDA, an unapproved new drug.
If this all sounds familiar, it should. The FDA pressed Natural Well to conduct a similar recall of the product earlier this year.
Meanwhile, the FDA is warning consumers not to take TimeOut Capsules because they contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.
TimeOut is labeled as 100% natural and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules.
Consumers who have TimeOut Capsules should stop using them immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.
The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.
Risk statement
The FDA advises that MasXtreme poses a similar threat to consumers because aminotadalafil 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, the FDA said.
MasXtreme is sold in blister packs containing one capsule. The product is distributed nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription. The company says it is not aware of any adverse events associated with the product.
Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441.
Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.
