Contaminated Drugs

The FDA has launched an investigation of weight loss products contaminated with undeclared chemicals and prescriptions drugs, many of which are marketed as dietary supplements. FDA laboratory tests revealed multiple undeclared ingredients in over-the-counter (OTC) weight loss products: bumetanide, cetilistat, fenproporex, fluoxetine, furosemide, phenolphthalein, phenytoin, rimonabant, and sibutramine.  The FDA is taking enforcement action to ensure these products are removed from the market.

  • Bumetanide, the active ingredient in prescription diuretic Bumex®, prompted a Boxed Warning because the drug may lead to massive fluid and electrolyte loss. Bumetanide can also elevate uric acid concentrations.
  • Cetilistat, an experimental obesity drug, could cause serious health risks. For example, cetilistat is contraindicated with warfarin and levothyroxine because it could cause an increased risk of bleeding and hypothyroidism. In addition, transplant patients taking anti-rejection drugs could suffer organ rejection while taking cetilistat. A majority of adverse events associated with cetilistat involve gastrointestinal side effects: rectal discharge, defecation urgency, and fecal incontinence. Use of cetilistat may cause oily or fatty bowel movements, which could lead to malnutrition and vitamin deficiency. Other safety concerns include: skin and subcutaneous tissue disorders; reduced serum concentrations of vitamin E, vitamin D, and beta-carotene; gallstones; and kidney stones.
  • Fenproporex, an unapproved stimulant and amphetamine derivative, can lead to serious adverse events: tachycardia, headache, increased respiratory rate, fever, elevated blood pressure, profuse sweating, constipation, diarrhea, blurred vision, dizziness, impaired speech, uncontrollable shaking or movements, numbness, insomnia, heart palpitations, arrhythmia, and sudden death. 
  • Fluoxetine, the active ingredient in the prescription anti-depressant Prozac®, belongs to the serotonin reuptake inhibitor (SSRI) drug class. Prozac and other SSRI drugs contain a Boxed Warning because they can increase the risk of suicidal ideation and suicide in children, teenagers, and young adults. Additional risks include: nausea, diarrhea, headache, insomnia, anxiety, rashes, and hives. Fluoxetine is also associated with the potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome, which is characterized by changes in metal state, blood pressure, pulse, muscle control, and body temperature
  • Furosemide, the active ingredient in Lasix®, is a powerful diuretic that is only available by prescription for people with congestive heart failure, high blood pressure, and edema. Furosemide can cause severe dehydration and electrolyte imbalance, including loss of potassium, calcium, sodium, and magnesium. Patients with allergies to sulfonamides may also be allergic to furosemide. Serious adverse events from furosemide overdose include: dehydration, seizures, gastrointestinal problems, lethargy, fatigue, seizures, kidney damage, fainting, and coma.  
  •  Phenolphthalein was an ingredient in OTC laxatives until 1999 after studies indicated that it presented a potential carcinogenic risk.
  •  Phenytoin is the active ingredient in Dilantin®, an anti-seizure medication. Consumers who are allergic or hypersensitive to phenytoin could suffer serious side effects.
  • Rimonabant is the active ingredient in Zimulti®, which was unanimously rejected for approval by the FDA due to increased risk of neurological and psychiatric effects.
  • Sibutramine is a controlled substance and the active ingredient in Meridia®, an anti-obesity prescription drug that was withdrawn from the U.S. market due to cardiovascular risks. The suggested dosage of some of the diet drugs that tested positive for sibutramine is more than 3 times the recommended daily dosage of Meridia. Therefore, even healthy consumers run the risk of serious adverse effects: increased blood pressure, palpitations, tachycardia, and seizures. Even a “normal” dose of sibutramine exposes people with a history of the following conditions to an increased risk of serious health threats:
  • Hypertension
  • Congestive heart failure, coronary artery disease, arrhythmias, stroke
  • Narrow angle glaucoma
  • Seizure
  • Liver problems
  • Predisposition to bleeding events
  • The concurrent use of certain medications, including sumatriptan, dihydroergotamine, dextromethorphan, meperidine, pentazocine, fentanyl, lithium, tryptophan, MAO inhibitors, and medications known to affect hemostasis or platelet function.

The table below lists the products identified by the FDA as being contaminated with undeclared ingredients:

Product Name Undeclared Ingredient(s)

   2 Day Diet®

   sibutramine

   2 Day Diet Slim Advance®

   sibutramine

   2x Powerful Slimming®

   sibutramine

   3 Day Diet®

   sibutramine

   3 Days Fit®

   sibutramine

   3x Slimming Power®

   sibutramine, phenytoin

   5x Imelda Perfect Slimming®

   sibutramine

   7 Day Herbal Slim®

   sibutramine

   7 Days Diet®

   sibutramine

   7 Diet®

   sibutramine

   7 Diet Day/Night Formula®

   sibutramine

   8 Factor Diet®

   sibutramine, phenolphthalein

   21 Double Slim®

   sibutramine

   24 Hours Diet®

   sibutramine, phenolphthalein

   999 Fitness Essence®

   sibutramine

   BioEmagrecim – Sample 1®

   fenproporex

   BioEmagrecim – Sample 2®

   fluoxetine, furosemide

   Body Creator®

   sibutramine

   Body Shaping®

   sibutramine

   Body Slimming®

   sibutramine

   Cosmo Slim®

   sibutramine

   Eight Factor Diet®

   sibutramine

   Extrim Plus®

   sibutramine, phenytoin

   Extrim Plus 24 Hour Reburn®

   sibutramine

   Fasting Diet®

   sibutramine

   Fatloss Slimming®

   sibutramine, phenolphthalein

   GMP®

   sibutramine

   Herbal Xenicol®

   cetilistat

   Imelda Fat Reducer®

   sibutramine

   Imelda Perfect Slim®

   sibutramine, phenolphthalein

   JM Fat Reducer®

   sibutramine

   Lida DaiDaihua®

   sibutramine

   Meili®

   sibutramine

   Meizitang®

   sibutramine

   Miaozi MeiMiaoQianZiJiaoNang®

   sibutramine

   Miaozi Slim Capsules®

   sibutramine

   Natural Model®

   sibutramine

   Perfect Slim®

   sibutramine

   Perfect Slim 5x®

   sibutramine, phenolphthalein

   Perfect Slim Up®

   sibutramine

   Phyto Shape®

   rimonabant

   Powerful Slim®

   sibutramine

   ProSlim Plus®

   sibutramine

   Reduce Weight®

   sibutramine

   Royal Slimming Formula®

   sibutramine, phenolphthalein

   Sana Plus®

   sibutramine

   Slim 3 in 1®

   sibutramine

   Slim 3 in 1 Extra Slim Formula®

   sibutramine

   Slim 3 in 1 Extra Slim Waist Formula®

   sibutramine

   Slim 3 in 1 M18 Royal Diet®

   sibutramine

   Slim 3 in 1 Slim Formula®

   sibutramine

   Slim Burn®

   sibutramine

   Slim Express 4 in 1®

   sibutramine

   Slim Express 360®

   sibutramine

   Slim Fast® (not to be confused with Slim-Fast®)

   sibutramine

   Slim Tech®

   sibutramine

   Slim Up®

   sibutramine

   Slim Waist Formula®

   sibutramine

   Slim Waistline®

   sibutramine

   Slimbionic®

   sibutramine

   Sliminate®

   sibutramine

   Slimming Formula®

   sibutramine

   Somotrim®

   sibutramine

   Starcaps®

   bumetanide

   Super Fat Burner®

   sibutramine, phenolphthalein

   Superslim®

   sibutramine

   Super Slimming®

   sibutramine

   Trim 2 Plus®

   sibutramine

   Triple Slim®

   sibutramine

   Venom Hyperdrive 3.0®

   sibutramine

   Waist Strength Formula®

   sibutramine

   Xsvelten®

   sibutramine

   Zhen de Shou®

   sibutramine, phenolphthalein

If you or a loved one has suffered from a serious injury while taking a weight loss drug or dietary supplement, please contact Andrews Thornton Higgins Razmara or a free case evaluation at 1-800-664-1734 or www.andrewsthornton.com.

 

Share this Post
Email this to someoneTweet about this on TwitterShare on FacebookShare on LinkedInShare on TumblrShare on Google+Print this page