FDA alert: All-natural weight loss supplements found tainted

The FDA has issued an alert to consumers and healthcare professionals about two dietary supplements sold for weight loss. Both have been found to be adulterated with prescription drugs and could endanger consumers.

According to the FDA’s Safety Information and Adverse Event Reporting Program, these products sold as natural diet aids have been recalled by the manufacturers. Consumers should discontinue taking them and return the products to the manufacturers.

STARCAPS

Balanced Health Products, Inc. has finally recalled STARCAPS due to the presence of the prescription drug, Bumetanide. This medication is a potent diuretic used in the treatment of edema associated with congestive heart failure, and liver and kidney disease, including nephrotic syndrome. It can cause serious fluid and electrolyte loss and elevations of uric acid. Bumetanide increases the risk of low blood pressure and fainting with resultant injuries, especially among those with normal blood pressure or who are already taking a high blood pressure medication. This drug is contraindicated for people allergic to sulfonamides. Those taking certain other medications are at risk for significant drug interactions with Bumetanide that can lead to toxicity, such as people taking digoxin and lithium.

The company’s recall notice, including specific lot number information, is available here.

StarCaps had been marketed over the internet as an all-natural product from Peru that combines papaya enzyme and garlic that’s been used since the time of ancient Greeks and Incas. A bottle of 30 tablets cost about $100 and it was billed as the diet supplement of the stars. The StarCaps website is frozen and currently says it has received notice of a problem in an NFL player and has ceased all product shipments until it can ensure StarCaps is safe and effective.

Bumetanide is a drug banned by the NFL, and Saints players Deuce McAllister, Will Smith and Charles Grant had reportedly tested positive for this substance. According to Pro Football Talk, Saints guard, Jamar Nesbitt, has been suspended four games for violation of drug policies and has filed suit against the manufacturer of “StarCaps,” for containing bumetanide unbeknownst to Nesbitt.

Why it took the company so long to issue a recall is unclear. Last year, in the November-December, 2007 issue of the Journal of Analytical Toxicology, researchers at the University of Utah reported that bumetanide can be used by athletes as a masking agent to increase urine production and reduce urinary concentrations of performance-enhancing drugs such as anabolic steroids, and to drop weight. The investigators had tested StarCaps and found that when administered to human volunteers, all of their urine samples tested positive for bumetanide. “Bumetanide was also detected in the StarCaps capsules at concentrations approaching therapeutic doses,” the researchers found. They concluded: “The results showed that unregulated dietary supplements may put consumers at risk for unwitting consumption of prescription medications, and that it is possible for athletes to inadvertently test positive for bumetanide and face disciplinary actions.”

Zhen De Shou Fat Loss Capsules

The second recall notice reported by FDA’s latest MedWatch safety report was issued by Fashion Sanctuary for its Zhen De Shou Fat Loss Capsules. This was in response to FDA analysis which found the product contained undeclared sibutramine, the prescription appetite suppressant. “This poses a potential 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,” the FDA reported.

The company’s recall notice includes ALL lot number codes and use-by dates and is available here.

Just because a product is used by stars and promises to be all natural and used since ancient times, does not make it true, safe or effective. No weight loss drug has ever been shown to be safe or effective for long-term weight loss. Not one.