FDA Expands Warning Re: Tainted Diet Pills

FDA NEWS RELEASE:  FDA Expands Warning to Consumers About Tainted Weight Loss Pills

List increases from 28 to 69 weight loss pill; Agency seeking recalls 

This press release was revised to include updated information.

The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk.

The tainted weight loss products are:

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), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. 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. 

“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, M.D., director, Center for Drug Evaluation and Research, FDA. “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.”

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 (rapid heart beat), 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.
 
Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

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FDA Tainted Weight Loss Products Alert

FDA NEWS RELEASE – U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

FDA Uncovers Additional Tainted Weight Loss Products
Agency alerts consumers to the finding of new undeclared drug ingredients

The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products:  

2 Day Diet
2 Day Diet Slim Advance
2x Powerful Slimming
3 Day Diet
3 Days Fit
3x Slimming Power
5x Imelda Perfect Slimming
7 Day Herbal Slim
7 Days Diet
7 Diet
7 Diet Day/Night Formula
8 Factor Diet
Eight Factor Diet
21 Double Slim
24 Hours Diet
999 Fitness Essence
BioEmagrecim
Body Creator
Body Shaping
Body Slimming
Cosmo Slim
Extrim Plus
Extrim Plus 24 Hour Reburn
Fasting Diet
Fatloss Slimming
GMP
Herbal Xenicol
Imelda Fat Reducer
Imelda Perfect Slim
JM Fat Reducer
Lida DaiDaihua
Meili
Meizitang
Miaozi MeiMaoQianZiJiaoNang
Miaozi Slim Capsules
Natural Model
Perfect Slim
Perfect Slim 5x
Perfect Slim Up
Phyto Shape
Powerful Slim
ProSlim Plus
Reduce Weihgt
Royal Slimming Formula
Sana Plus
Slim 3 in 1
Slim 3 in 1 Extra Slim Formula
Slim 3 in 1 Extra Slim Waist Formula
Slim 3 in 1 M18 Royal Diet
Slim 3 in 1 Slim Formula
Slim Burn
Slim Express 4 in 1
Slim Express 360
Slim Fast*
Slim Tech
Slim Up
Slim Waist Formula
Slim Waistline
Slimbionic
Sliminate
Slimming Formula
Somotrim
Starcaps
Super Fat Burner
Superslim
Super Slimming
Trim 2 Plus
Triple Slim
Venom Hyperdrive 3.0
Waist Strength Formula
Xsvelten
Zhen de Shou
 

* This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”.  The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.

“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 maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted.

The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:

• sibutramine (an appetite suppressant available by prescription only and a controlled substance)
• fenproporex – a controlled substance not approved for marketing in the United States;
• fluoxetine – an antidepressant available by prescription only;
• bumetanide – a potent diuretic available by prescription only;
• furosemide – a potent diuretic available by prescription only;
• rimonabant – a drug not approved for marketing in the United States;
• cetilistat – an experimental obesity drug not approved for marketing in the United States;
• phenytoin – an anti-seizure medication available by prescription only; and
• phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

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

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program.

Source:  Information on FDA’s Initiative Against Contaminated Weight Loss Products

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