FDA warns against “Fruit & Plant Slimming”

P.Naina MohamedPharmacologist

IntroductionThe Food and Drug Administration (FDA) is advising

consumers not to purchase or use “Fruit & Plant”, a product promoted and sold for weight loss on various websites and in some retail stores, on 17th June 2013.

FDA laboratory analysis confirmed that Fruit & Plant contains sibutramine.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.

Laboratory analysis also confirmed that Fruit & Plant Slimming contains phenolphthalein. Phenolphthalein was an ingredient in some over-the-counter (OTC) laxative products until 1999 when FDA reclassified the ingredient as “not generally recognized as safe and effective.” 

Possible Mechanism of actionFruit & Plant

Contains Sibutramine

Affects Ventromedial & lateral hypothalamic regions of CNS

Blockade of Serotonin (5-HT), Noradrenaline and Dopamine reuptake

Increase the neurotransmission of Serotonin (5-HT), Noradrenaline and Dopamine

Rise of Satiety (Absence of hunger after eating) and reduction of hunger

Loss of Appetite

Risks of Fruit & PlantUndeclared ingredient (Sibutramine)

Inhibit the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine)

Increased neurotransmission of mono amines

Elevated blood pressure and Heart

Increased risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases

 

Serious Drug InteractionsUndeclared ingredient (Sibutramine)

Interacts with Mono amine oxidase inhibitors (MAOIs)

Inhibition of metabolism of monoamines

Increased plasma level of monoamines

Serious, sometimes fatal, reactions (“serotonin syndrome”)

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.

Other Drug Interactions

Undeclared ingredient (Sibutramine)

Interacts with Decongestants (Ephedrine or Pseudoephedrine)

May raise blood pressure or heart rate

Other Drug Interactions

Undeclared ingredient (Sibutramine)

Interacts with CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, etc.

Increase the plasma level of Sibutramine

Toxicity of Sibutramine

FDA WarningsFDA 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. 

FDA Warnings FDA has requested market withdrawal after reviewing data from

the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm228830.htm

References http://www.fda.gov/Drugs/ResourcesForYou/Consumers/

BuyingUsingMedicineSafely/MedicationHealthFraud/ucm357419.htm?source=govdelivery

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References http://www.fda.gov/safety/medwatch/

safetyinformation/safetyalertsforhumanmedicalproducts/ucm228830.htm

http://www.tga.gov.au/safety/alerts-medicine-sibutramine-101008.htm

http://www.medsafe.govt.nz/hot/media/2010/SibutramineOct2010.asp

http://www.bmj.com/content/340/bmj.c824