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Weight Loss Products Containing Undeclared Active Ingredients

July 17, 2009

FDA has discovered the following weight loss products contain undeclared, potentially harmful ingredients. These products may be contaminated with sibutramine (a prescription appetite suppressant), rimonabant (a drug not approved in the U.S.), phenytoin (a prescription anti-seizure drug), phenolphthalein (a chemical suspected to cause cancer, fenproporex (a controlled substance not approved in the U.S.), fluoxetine (a prescription antidepressant), furosemide (a prescription diuretic), bumetanide (a prescription diuretic), or cetilistat (a drug not approved in the U.S.):

Sibutramine: 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, 21 Double Slim, 24hours Diet, 999 Fitness Essence, Body Creator, Body Shaping, Body Slimming, Botanical Weight Loss, Cosmo Slim, Eight Factor Diet, Extrim Plus 24 Hour Reburn, Fasting Diet, GMP, Imelda Fat Reducer, Imelda Perfect Slim, JM Fat Reducer, Lida DaiDaihua, Meili, Meizitang, Miaozi, MeiMiaoQianZiJiaoNang, Miaozi Slim Capsules, Natural Model, One Weight Loss Pill, Perfect Slim, Perfect Slim 100% Natural Herbal Essence, Perfect Slim Up, Powerful Slim, ProSlim Plus, Reduce Weight, 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, SlimDemand, Slim Express 360, Slim Express 4 in 1, Slim Fast*, Slim Fast 2*, Slim Tech, Slim Up, Slim Waist Formula, Slim Waistline, Slimbionic, Sliminate, Slimming Formula, Somotrim, Super Fat Burner, Super Slimming, Trim 2 Plus, Trim Plus 2, Triple Slim, Venom Hyperdrive 3.0, Waist Strength Formula, Xsvelten

Sibutramine + phenytoin: 3x Slimming Power, Extrim Plus

Sibutramine + phenolphthalein: 8 Factor Diet, 24 Hours Diet, Fatloss Slimming, Imelda Perfect Slim, Perfect Slim 5x, Royal Slimming Formula, Superslim, Zhen de Shou

Rimonabant: Phyto Shape

Fenproporex: BioEmagrecim, sample 1

Fluoxetine + furosemide: BioEmagrecim, sample 2

Cetilistat: Herbal Xenicol

Bumetanide: Starcaps

*Do not confuse with Slim-Fast® Meal replacement and related products, which are not associated in any way with the products on this list.

All of these undeclared ingredients may cause harm to the patient. Sibutramine and phenytoin are approved in the U.S. for prescription use only. Sibutramine can increase heart rate and blood pressure. Patients with underlying heart disease may have an increased risk of adverse events. Phenytoin was only found in trace amounts; however, patients allergic to phenytoin may be at risk for serious adverse reactions. Phenolphthalein and rimonabant are not approved for use in the U.S. due to safety concerns. Phenolphthalein is considered potentially carcinogenic. In Europe, rimonabant has been linked to 5 deaths and many psychiatric and neurological adverse reactions. Fenproporex can cause many adverse effects including changes in blood pressure, heart rate and heart rhythm. Cetilistat is an experimental drug for which safety has not been established. Cetilistat can cause drug interactions, vitamin deficiencies, and serious reactions in susceptible individuals. Fluoxetine, a prescription antidepressant, carries a warning of suicide risk in children, adolescents, and young adults. Fluoxetine can also cause potentially fatal serotonin syndrome or Neuroleptic Malignant Syndrome among other adverse reactions and should only be used under the care of a healthcare provider. Bumetanide and furosemide are prescription diuretics which may cause fluid and electrolyte imbalances, hypotension, or allergic reactions, and should also only be used under the care of a prescriber.

Educate patients not to use these products and if they have already used them, to consult with their healthcare provider immediately. Educate patients to be suspect of dietary supplements which promise an easy solution, miraculous cure, or “too good to be true” results for obesity.

FDA is seeking recall of these products. Information on recalls and returning these products is found at http://www.fda.gov/opacom/7alerts.html.

Additional information is available at the following links:

Updated
July 17, 2009; April 23, 2009; March 24, 2009; December 24, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.