FDA's warning against “Toxin Discharged Tea”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

§  On 17^th June 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “Toxin Discharged Tea”.

§  Toxin Discharged Tea is a product promoted and sold for weight loss on various websites and in some retail stores.

§   FDA laboratory analysis confirmed that “Toxin Discharged Tea” contains Fluoxetine.

§  Fluoxetine is a Selective Serotonin Reuptake Inhibitor (SSRI) and is approved to treat depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD).

§  SSRIs including Fluoxetine are not approved by the U.S. Food and Drug Administration (FDA) for weight loss.

§  Due to the content of Fluoxetine, Toxin Discharged Tea may cause some serious Adverse effects including Serotonin syndrome, Suicidal thoughts, Depression, worsening, Mania, Prolonged QT interval, Serious Bleeding, Seizure, etc.

§  Due to the content of Fluoxetine, Toxin Discharged Tea use is contraindicated in patients taking…

Ø Metoclopramide

Ø MAO Inhibitors (Linezolid, Nialamide, Toloxatone,  Methylene Blue (IV), Clorgyline, etc)

Ø CYP2D6 substrates (Thioridazine, Pimozide, Iloperidone)

Ø QT Interval Prolonging Drugs like Terfenadine, Mesoridazine, etc.

§  Toxin Discharged Tea (Fluoxetine) may also have major interaction with drugs such as…

Ø  Tricyclic antidepressants (Imipramine, Desipramine)

Ø Serotonergic agents (Sumatriptan, Rizatriptan or other antidepressants)

Ø Class Ia Antiarrhythmic Agents (Quinidine, Procainamide, Disopyramide)

Ø Phenothiazines (Chlorpromazine, Fluphenazine)

Ø Anticoagulants (Warfarin)

Ø Antiplatelets ( Clopidogrel, Ticlopidine,  Prasugrel)

Ø NSAIDs (Ibuprofen, Aspirin)

§  The concomitant use of Toxin Discharged Tea (Fluoxetine) and Metoclopramide is contraindicated due to increased risk of Extrapyramidal reactions or Neuroleptic malignant syndrome (Fever, sweating, confusion, Muscle stiffness).

§  It is contraindicated to use Toxin Discharged Tea (Fluoxetine) and MAO Inhibitors (Linezolid, Nialamide, Toloxatone,  Methylene Blue (IV), Clorgyline, etc) due to CNS toxicity or serotonin syndrome (Restlessness, myoclonus, changes in mental status, hyperreflexia, diaphoresis, shivering, and tremor).

§  CYP2D6 substrates like Thioridazine, Pimozide, Iloperidone may interact with Toxin Discharged Tea (Fluoxetine) and risk of additive QT-interval prolongation which leads to the contraindication.

§  Coadministration of Toxin Discharged Tea (Fluoxetine) and QT Interval Prolonging Drugs like Terfenadine, Mesoridazine, Bepridil, Sertraline, Erythromycin, Telithromycin, is contraindicated due to increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest).

§  FDA advises the Consumers to exercise caution before purchasing any product typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural”.