FDA's warning against asset bold
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FDA's warning against asset bold

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On 16th May 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use Asset Bold.

On 16th May 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use Asset Bold.

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  • 1. FDA’s advice on “Asset Bold” Dr. P.NaiNa MohaMeD PharMacologist
  • 2. Introduction On 16th May 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “Asset Bold”. “Asset Bold” is promoted and sold for weight loss and sold on various websites and in some retail stores.  FDA laboratory analysis confirmed that “Asset Bold” contains Sibutramine. Sibutramine is a controlled substance and it was removed from the market in October 2010 for safety reasons. 
  • 3. Possible Mechanism of action
  • 4. Risks of Asset Bold
  • 5. Contraindications of Asset Bold (Sibutramine)  “Asset Bold” should not be used by the patient who has..  History of cerebrovascular disease (stroke or transient ischemic attack)  History of congestive heart failure  History of coronary artery disease (eg, angina, myocardial infarction)  History of cardiac arrhythmias  History of peripheral arterial occlusive disease  Uncontrolled hypertension.  Major eating disorders, major (eg, anorexia nervosa or bulimia nervosa)  Concomitant use with MAOIs  Concomitant use with other centrally acting weight loss drugs
  • 6. Serious Drug Interactions
  • 7. Interaction with Antidepressants
  • 8. Interaction with NSAIDs
  • 9. Interaction with Decongestants
  • 10. Interaction with CYP3A4 Inhibitors
  • 11. 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. 
  • 12. 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 Sibutramine (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/safetyalertsforhumanmedica
  • 13. References http://www.fda.gov/Drugs/ResourcesForYou/Consume http://www.micromedexsolutions.com 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
  • 14. References  http://www.fda.gov/safety/medwatch/safetyinformati on/safetyalertsforhumanmedicalproducts/ucm22883 0.htm  http://www.tga.gov.au/safety/alerts-medicine- sibutramine-101008.htm  http://www.medsafe.govt.nz/hot/media/2010/Sibutra mineOct2010.asp  http://www.bmj.com/content/340/bmj.c824