HEALTH

Study shows cranberry extract effective in UTI prevention

BY Michael Johnsen

BIRMINGHAM, England A study recently published in the Journal of Antimicrobial Chemotherapy determined that supplementing with a cranberry extract was almost as effective as taking low-dose trimethoprim in preventing urinary tract infections in older women.

“Trimethoprim had a very limited advantage over cranberry extract in the prevention of recurrent UTIs in older women and had more adverse effects,” study authors determined. “Our findings will allow older women with recurrent UTIs to weigh up with their clinicians the inherent attractions of a cheap, natural product like cranberry extract whose use does not carry the risk of antimicrobial resistance or super-infection with Clostridium difficile or fungi.”

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Reality Coalition applauds FDA alert on weight loss product safety

BY Michael Johnsen

NEW YORK The Reality Coalition, a group of experts and organizations around overweight and obesity, on Tuesday applauded the Food and Drug Administration’s efforts to recall and warn consumers about dietary supplements that claim to provide weight loss and contain undeclared, active pharmaceutical ingredients.

“Consumers should avoid dietary weight loss products that pose serious health risks,” said Reality Coalition co-chair George Blackburn. “To the best of my knowledge, identifying 25 tainted weight loss products is the largest action by the FDA.”

“We have always argued that weight loss supplements are not effective and unregulated, and now that these products have been shown to contain undeclared ingredients [that] may endanger health, this action by the FDA is of great urgency,” added Reality’s other co-chair MRC Greenwood.

The announcement follows FDA action on Monday—the agency issued an alert to consumers not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

The Reality Coalition is a group of experts and organizations on obesity, nutrition, diabetes and healthcare policy who share the common goal of advancing an agenda for realistic approaches to weight loss to achieve improved public health.  

The Reality Initiative was launched in 2006 and is supported by an educational grant from GlaxoSmithKline Consumer Healthcare, marketer of the over-the-counter weight loss drug alli (orlistat).  

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FDA issues warning on weight loss products containing undeclared Rx ingredients

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Monday issued an alert to consumers not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent).

Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

These weight loss products, some of which are inappropriately marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores, the FDA noted. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

The following list of brand names are associated with the warning:

Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hours Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida, DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0.

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