FDA’s warning against

“Sport Burner”

Dr. P.Naina MohamedPharmacologist

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.

Serious ADR• Due to the content of Fluoxetine, Sport Burner

may cause some serious Adverse effects such as…Serotonin syndromeSuicidal thoughts, Depression, worsening,

Mania.Prolonged QT intervalSerious BleedingSeizure (0.2% )Anaphylactoid reactionErythema multiformeHyponatremia

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

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)

Interaction with CYP2D6

SubstratesSport 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

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

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

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

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)

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)

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

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

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

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.

References• http://

www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm401534.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

• 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, 11eLeonard G. Gomella, Steven A. Haist

References• http://www.micromedexsolutions.com• http://

www.nlm.nih.gov/medlineplus/druginfo/meds/a689006.html

• http://www.nhs.uk/medicine-guides/pages/medicineoverview.aspx?condition=Depression&medicine=fluoxetine

• http://www.medicinenet.com/fluoxetine/article.htm

• http://www.rxlist.com/prozac-drug/clinical-pharmacology.htm

• http://www.merckmanuals.com/professional/lexicomp/fluoxetine.html