FDA’s warning against sport burner

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On 17th June 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sport Burner.
· FDA laboratory analysis confirmed that Sport Burner contains fluoxetine.

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FDA’s warning against sport burner

  1. 1. FDA’s warning against “Sport Burner” Dr. P.Naina Mohamed Pharmacologist
  2. 2. Introduction • On 17th June 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Sport Burner ”. • Sport Burner is promoted and sold for weight loss on various websites and in some retail stores. • FDA laboratory analysis confirmed that contains Fluoxetine. • Fluoxetine is a elective serotonin reuptake inhibitor (SSRI) and is approved to treat depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD). • The Obesity Education Initiative guidelines from the National Heart, Lung, and Blood Institute do not address SSRIs in the pharmacologic management of obesity. • SSRIs are not approved by the U.S. Food and Drug Administration (FDA) for weight loss.
  3. 3. Serious ADR • Due to the content of Fluoxetine, Sport Burner may cause some serious Adverse effects such as… Serotonin syndrome Suicidal thoughts, Depression, worsening, Mania. Prolonged QT interval Serious Bleeding Seizure (0.2% ) Anaphylactoid reaction Erythema multiforme Hyponatremia
  4. 4. Interaction with Metoclopramide Toxin Discharged Tea Undeclared Fluoxetine Interact with Metoclopramide Increased risk of Extrapyramidal reactions or Neuroleptic malignant syndrome (Fever, sweating, confusion, Muscle stiffness) Contraindicated
  5. 5. Interaction with MAO Inhbitors Sport Burner Undeclared Fluoxetine Interact with MAO Inhibitors like Linezolid, Nialamide, Toloxatone, Methylene Blue (IV), Clorgyline MAO Inhibitors block serotonin metabolism Increased plasma levels of serotonin CNS toxicity or serotonin syndrome (Restlessness, myoclonus, changes in mental status, hyperreflexia, diaphoresis, shivering, and tremor)
  6. 6. Interaction with CYP2D6 Substrates Sport Burner Undeclared Fluoxetine Interact with CYP2D6 substrates like Thioridazine, Pimozide, Iloperidone Fluoxetine inhibits CYP2D6-mediated metabolism Elevated plasma levels of Thioridazine, Pimozide, Iloperidone Increased risk of additive QT-interval prolongation Contraindicated
  7. 7. Interaction with QT Interval Prolonging Drugs Sport Burner Undeclared Fluoxetine Interact with QT Interval Prolonging Drugs like Terfenadine, Mesoridazine, Bepridil, Sertraline, Erythromycin, Telithromycin Additive effects on QT prolongation Increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest) Contraindicated
  8. 8. Interaction with Tricyclic Antidepressants (TCAs) Sport Burner Undeclared Fluoxetine Interact with Tricyclic Antidepressants (Imipramine, Desipramine ) Increased plasma levels of TCAs Increased risk of tricyclic antidepressant toxicity, QT prolongation and serotonin syndrome
  9. 9. Interaction with Serotonergic agents Sport Burner Undeclared Fluoxetine Interact with Serotonergic agents (Sumatriptan, Rizatriptan or other antidepressants) Increased risk of serotonin syndrome (mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms
  10. 10. Interaction with Class Ia Antiarrhythmic Agents Sport Burner Undeclared Fluoxetine Interact with Class Ia Antiarrhythmic Agents (Quinidine, Procainamide, Disopyramide) Additive effects on QT prolongation Increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest)
  11. 11. Interaction with Phenothiazines Sport Burner Undeclared Fluoxetine Interact with Phenothiazines (Chlorpromazine, Fluphenazine) Additive effects on QT prolongation Increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest)
  12. 12. Interaction with Anticoagulants Sport Burner Undeclared Fluoxetine Interact with Anticoagulants (Warfarin) Fluoxetine blocks the uptake of serotonin by platelets Decreased function of platelets Increased risk of Bleeding
  13. 13. Interaction with Antiplatelets Sport Burner Undeclared Fluoxetine Interact with Antiplatelets ( Clopidogrel, Ticlopidine, Prasugrel) Fluoxetine blocks the uptake of serotonin by platelets Decreased function of platelets Increased risk of Bleeding
  14. 14. Interaction with NSAIDs Sport Burner Undeclared Fluoxetine Interact with NSAIDs (Ibuprofen, Aspirin) Fluoxetine blocks the uptake of serotonin by platelets Decreased function of platelets Increased risk of upper gastrointestinal (GI) Bleeding
  15. 15. Conclusion  FDA warns the Consumers should stop using this product immediately and throw it away.  FDA advises the Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.  FDA announces to the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”  FDA claims that they are unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.  FDA advises the Consumers to exercise caution before purchasing any product in the above categories.
  16. 16. References • http://www.fda.gov/Drugs/ResourcesForYou/Co nsumers/BuyingUsingMedicineSafely/Medicatio nHealthFraud/ucm401534.htm?source=govdeliv ery&utm_medium=email&utm_source=govdeliv ery • Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e Laurence L. Brunton, Bruce A. Chabner, Björn C. Knollmann • Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor • Clinician's Pocket Reference, 11e Leonard G. Gomella, Steven A. Haist
  17. 17. References • http://www.micromedexsolutions.com • http://www.nlm.nih.gov/medlineplus/druginf o/meds/a689006.html • http://www.nhs.uk/medicine- guides/pages/medicineoverview.aspx?con dition=Depression&medicine=fluoxetine • http://www.medicinenet.com/fluoxetine/art icle.htm • http://www.rxlist.com/prozac-drug/clinical- pharmacology.htm • http://www.merckmanuals.com/professiona l/lexicomp/fluoxetine.html

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