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FDA has new tool to track supplement warnings

Consumer Reports News: April 06, 2011 08:24 AM

The U.S. Food and Drug Administration this week unveiled a new, consumer-friendly search engine that provides easy access to information about product recalls and warnings. We used it to round up recent ones involving dietary supplements.

March 28: AVNS Inc announced a recall of The BEST Enhancer after it was informed by the manufacturer, Drive Total Energy, that FDA testing had found it contained sulfoaildenafil, a compound similar to sildenafil, the active ingredient in Viagra. The compound is potentially dangerous because it can interact with some prescription drugs, notably nitroglycerin, and lower blood pressure to dangerous levels. AVNS urges consumers to discontinue use and return the product to the place of purchase for a full refund.

March 25: USA Far Ocean Group Inc., of Alhambra, Calif., announced a nationwide recall of X-Hero and Male Enhancer supplements. FDA analysis found that a sample of X-Hero contained sulfosildenafil (another Viagra-like compound) and a sample of Male Enhancer contained tadalafil, the active ingredient in Cialis. The company’s press release shows the specific products involved in the recall. Consumers should stop using the products immediately and contact their physician if they experience problems.

March 22: USA Far Ocean Group Inc., announced a nationwide recall of U-Prosta Natural Support for Prostate Health after an FDA analysis found terazosin, the active ingredient in Hytrin, a prescription drug used to treat symptoms caused by an enlarged prostate. Adverse effects include low blood pressure, dizziness, and fainting. Patients who are currently being treated with prescription medications for high blood pressure or enlarged prostate would be at notably increased risk. The company’s press release contains the descriptions of the involved products. Consumers should stop using them immediately and return the products to the place of purchase for a full refund.

March 16: The FDA advised consumers to stop using “Black Ant,” a sexual enhancement product that contained sildenafil. The product tested had three times the starting dosage for Viagra, according to the FDA. Consumers should throw the product away, the FDA said. Consumers who have experienced any side effects should consult a physician.

March 15: Shaping Beauty, Inc., of Southampton, PA, announced a nationwide recall of all lots of its supplement product, Celerite Slimming Tea, which FDA testing found contained sibutramine, the active ingredient in the prescription appetite suppressant drug Meridia that was withdrawn from the market in 2010 because of an increased risk of cardiovascular events such as heart attack and stroke. Sibutramine can cause a rise in blood pressure, pulse, or both, and can pose a significant risk to people with a history of arrhythmias, coronary artery disease, congestive heart failure, or stroke, according to the FDA.

Bottom line: Take care when purchasing any dietary supplement, especially those sold for sexual enhancement or weight loss. Read more about dangerous supplements, the risks they often pose, and the precautions you should take.

Sources
Recalls, Market Withdrawals, & Safety Alerts [FDA]

AVNS, Inc. Issues a Voluntary Recall of THE BEST Enhancer [FDA]

Product labels [FDA]

USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of X-Hero and Male Enhancer, Products Marketed as Dietary Supplements [FDA]

USA Far Ocean Group, Inc. Issues Voluntary Nationwide Recall of U-Prosta, a Product Marketed As a Dietary Supplement That Contains Undeclared Terazosin Hydrochloride [FDA]

Public Notification: "Black Ant” Contains Undeclared Drug Ingredient [FDA]

Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Tea Found to Contain an Undeclared Drug Ingredient [FDA]

Doug Podolsky


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