UPDATED: FDA Issues Health Fraud Alerts for Sexual Enhancement and Weight Loss Supplements
Late last week, the Food and Drug Administration (FDA) released a new batch of health fraud alerts for sexual enhancement and weight loss supplements.
These alerts are reserved primarily for over-the-counter items that claim to treat disease or improve health, but have not proven their effectiveness. In addition to wasting billions of consumers' dollars each year, health scams can lead patients to delay proper treatment and cause serious injuries.
Affected supplements include:
Many of these supplements contain undeclared sildenafil, the active ingredient in the FDA-approved prescription drug Viagra. Used to treat erectile dysfunction (ED), the ingredient can interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Others contain hydroxythiohomosildenafil and thiosildenafil, an ingredient structurally similar to sildenafil and tadalafil, the FDA-approved active ingredient in Cialis.
- S.W.A.G.G.E.R Extreme Capsules: silenafil
- APEXXX: sildenafil
- Fuel Up High Octane: hydroxythiohomosildenafil
- Fuel Up Plus: hydroxythiohomosildenafil
- Paradise Suplemento Natural Ultra Plus Capsules: sildenafil
- Sex-Love Secret Code Capsules: sildenafil
- Super Dragon 6000 Capsules: sildenafil
- Ultra SX Capsules: sildenafil
- Wild Sexx Capsules: tadalafil
- Power Khan: sildenafil and thiosildenafil
- Basha Nut 100% Fruit Soft Gel Capsules: sibutramine
- Lishou Slimming Coffee: sibutramine
- Tip-Top Shape: sibutramine
- Xtreme Fat Burner Capsules: phenolphthalein and sildenafil.
FDA analysis found that many of these supplements contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Other supplements contained phenolphthalein, a chemical that is not an active ingredient in any approved drug in the United States. Studies indicate that it presents a cancer-causing risk.