Xiyouji qingzhi


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Xiyouji qingzhi is recalled from the market which was promoted for weight loss.

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Xiyouji qingzhi

  1. 1. “Xiyouji Qingzhi” recalled from market P.Naina Mohamed Pharmacologist
  2. 2. Introduction Dolphin Intertrade Corp. voluntarily recalled “Xiyouji Qingzhi” a Weight Loss Supplement. Xiyouji Qingzhi has been found to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Xiyouji Qingzhi Weight Loss Supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of # 30 capsules of 300mg. The affected Xiyouji Qingzhi Weight Loss Supplement, includes all lots. The products were distributed from May 2011 to May 2013.
  3. 3. Possible Mechanism of action Xiyouji Qingzhi 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
  4. 4. Risks of Xiyouji Qingzhi Undeclared ingredient (Sibutramine) Inhibit the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine) Increased neurotransmission of mono amines Elevated blood pressure and Heart rate Increased risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases
  5. 5. 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.
  6. 6. Other Drug Interactions Undeclared ingredient (Sibutramine) Interacts with Decongestants (Ephedrine or Pseudoephedrine) May raise blood pressure or heart rate
  7. 7. Other Drug Interactions Undeclared ingredient (Sibutramine) Interacts with CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, etc. Increase the plasma level of Sibutramine Toxicity of Sibutramine
  8. 8. FDA Warnings 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.
  9. 9. 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/safetyalertsf orhumanmedicalproducts/ucm228830.htm
  10. 10. References  http://www.fda.gov/Safety/Recalls/ucm35 9040.htm?source=govdelivery  CURRENT Diagnosis & Treatment: Gastroenterology, Hepatology, & Endoscopy, 2e Norton J. Greenberger, Richard S. Blumberg, Robert Burakoff  Clinician's Pocket Reference, 11e Leonard G. Gomella, Steven A. Haist  Harrison's Online Featuring the complete contents of Harrison's Principles of Internal Medicine, 18e  Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor
  11. 11. References  http://www.fda.gov/safety/medwatch/safetyinfor mation/safetyalertsforhumanmedicalproducts/uc m228830.htm  http://www.tga.gov.au/safety/alerts-medicine- sibutramine-101008.htm  http://www.medsafe.govt.nz/hot/media/2010/Sib utramineOct2010.asp  http://www.bmj.com/content/340/bmj.c824