FDA's warning against “B-Perfect”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

§  On 05^th June 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “B-Perfect”.

§  B-Perfect is a product promoted and sold for weight loss on www.icanb-perfect.com  and possibly sold in some retail stores.

§   FDA laboratory analysis confirmed that “B-Perfect” contains Sibutramine and Phenolphthalein.

§  The undeclared ingredient (Sibutramine), increase the risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases by inhibiting the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine).

§  Sibutramine is contraindicated in patients with heart and vascular diseases.

§  Due to the content of sibutramine, B-Perfect may interact with many drugs including…

Ø MAO Inhibitors (Selegiline, Rasagiline, Clorgyline, Pargyline, etc)

Ø Antidepressants (SSRI (Escitalopram, Fluoxetine), SNRI (Venlafaxine, Duloxetine) & Tricyclic antidepressants (Amitriptyline, Imipramine)

Ø NSAIDs (Ibuprofen, Diclofenac, etc.)

Ø Decongestants (Ephedrine or Pseudoephedrine)

Ø CYP3A4 enzyme inhibitors (Ketoconazole, Erythromycin, etc.)

§  Serious, sometimes fatal, reactions  such as Excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, and tachycardia may occur due to the interaction of sibutramine and MAO Inhibitors which increase the plasma levels monoamines (Serotonin (5-HT), Noradrenaline and Dopamine).

§  Excessive serotonergic stimulation and Increased risk of serotonin syndrome (Hypertension, Hyperthermia, Myoclonus, Mental status changes) may be resulted due to the interaction of sibutramine and antidepressants.

§  The risk of upper gastrointestinal (GI) Bleeding may be increased by the concomitant use of sibutramine and NSAIDs.

§  The Blood pressure and Heart rate may be elevated by the coadministration of sibutramine and decongestants.

§  Sibutramine toxicity may be resulted by concomitant use of sibutramine and CYP3A4 enzyme inhibitors.

§  Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.

§  Studies have indicated that Phenolphthalein presents a cancer-causing risk. 

§  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”.