FDA Seeks Recall Of 25 Weight Loss Pills With Potentially Unsafe Ingredients

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Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals;  Nutrition / Diet
Article Date: 23 Dec 2008 - 3:00 PDT

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The Food and Drug Administration (FDA) in the United States is seeking to recall 23 different products marketed as for weight loss because they contain undeclared active pharmaceutical substances that may pose serious health risks to consumers. The products are marketed over the Internet and in retail stores, and in some cases are described as "dietary supplements" .

The federal agency posted the alert on its website on Monday, warning consumers nationwide not to purchase any of the following tainted weight loss products:

• 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
• Venom Hyperdrive 3.0

After analysing these products the FDA found they contained undeclared active pharmaceutical ingredients, in some case in amounts that exceeded FDA-recommended levels, thereby putting consumers' health at risk.

The director of the FDA's Center for Drug Evaluation and Research, Dr Janet Woodcock said:

"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."

"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," she added.

Among the undeclared ingredients they found were:

• Sibutramine: this can cause high blood pressure, palpitations, tachycardia, seizures, heart, attack, and stroke. It can also interact with other medications to cause adverse reactions. Its safety for use by children under 16 or pregnant or breastfeeding women is unknown.


• Rimonabant: an appetite suppressant that has been evaluated but not approved by the FDA for sale in the US. This drug is approved for sale in Europe, where is has been implicated in 5 deaths and 720 reported adverse reactions in the last two years. The drug has also been linked to increased risk of depression and suicidal thoughts.


• Phenytoin: an anti-seizure drug.


• Phenolphthalein: a suspected carcinogen that is used to test for acidity in chemical experiments.

Some of the products are advertised as containing only "herbal" or "natural" ingredients, but in reality contain potentially harmful substances that are not listed on product labels or advertisements. The FDA warns that:

"These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers."

If you have bought or own any of these products you should stop taking them and talk to your doctor immediately said the FDA, who also advises consumers to talk to a healthcare professional before buying any weight loss products.

The federal agency has inspected a number of firms selling or connected with the selling of these illegal products and is seeking to recall the products. The FDA may proceed with a number of enforcement actions, escalating from warning letters to seizures, injunctions and criminal prosecution.

Whether you are a consumer or healthcare professional, you can report serious adverse events or side effects, or problems with product quality to the FDA's MedWatch Adverse Event Reporting program in any of the following ways:

-- Going online at http://www.fda.gov/MedWatch/report.htm
-- Faxing to the fax number: (800) FDA-0178.
-- Calling phone number: (800) FDA-1088.
-- Writing to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
-- Filling in postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and then mailing to above address.

Click here for more information about these weight loss products and consumer-directed questions and answers.

Sources: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today