FDA warns against “Paiyouji Plus ”

P.Naina MohamedPharmacologist

IntroductionThe Food and Drug Administration (FDA) is

advising consumers not to purchase or use “Paiyouji Plus”, 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 Paiyouji Plus contains sibutramine.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

Possible Mechanism of action

Paiyouji Plus

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 Paiyouji PlusUndeclared 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 Interactions

Undeclared 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/ucm357423.htm?source=govdelivery

CURRENT Diagnosis & Treatment: Gastroenterology, Hepatology, & Endoscopy, 2eNorton J. Greenberger, Richard S. Blumberg, Robert Burakoff

Clinician's Pocket Reference, 11eLeonard G. Gomella, Steven A. Haist

Harrison's Online Featuring the complete contents of Harrison's Principles ofInternal Medicine, 18e

Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor

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

yinformation/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