FDA’S ADVICE ON
“NATURAL BODY
SOLUTION”
Dr. P.Naina Mohamed
Pharmacologist
INTRODUCTION
 On 05th
May 2014, the Food and Drug
Administration (FDA) is advising consumers not
to purchase or use “Natu...
POSSIBLEMECHANISM
OFACTION
RISKSOFNATURAL
BODYSOLUTION
CONTRAINDICATIONS OF
NATURAL BODY SOLUTION
(SIBUTRAMINE)
 “Natural Body Solution” should not be used by the
patient who h...
SERIOUSDRUG
INTERACTIONS
INTERACTIONWITH
ANTIDEPRESSANTS
INTERACTIONWITH
NSAIDS
INTERACTIONWI
DECONGESTANT
INTERACTIONWITH
CYP3A4INHIBITORS
FDAWARNINGS• FDA warns the Consumers should stop using this
product immediately and throw it away. 
• FDA advises the Cons...
FDAWARNING
 FDA has requested market withdrawal after reviewing data
from the Sibutramine Cardiovascular Outcomes Trial
(...
REFERENCES

http://www.fda.gov/Drugs/ResourcesForYou/Co

http://www.micromedexsolutions.c
om
CURRENT Diagnosis &
Treatm...
REFERENCES
 http://www.fda.gov/safety/medwatch/safetyinfor
mation/safetyalertsforhumanmedicalproducts/uc
m228830.htm
 ht...
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FDA's Advice on Natural body solution

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On 05th May 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “Natural Body Solution” which claims to be a natural remedy for weight loss.

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FDA's Advice on Natural body solution

  1. 1. FDA’S ADVICE ON “NATURAL BODY SOLUTION” Dr. P.Naina Mohamed Pharmacologist
  2. 2. INTRODUCTION  On 05th May 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “Natural Body Solution”.  “Natural Body Solution” is promoted and sold for weight loss and sold on various websites and in some retail stores.   FDA laboratory analysis confirmed that “Natural Body Solution” contains Sibutramine.  Sibutramine is a controlled substance and it was removed from the market in October 2010 for safety reasons. 
  3. 3. POSSIBLEMECHANISM OFACTION
  4. 4. RISKSOFNATURAL BODYSOLUTION
  5. 5. CONTRAINDICATIONS OF NATURAL BODY SOLUTION (SIBUTRAMINE)  “Natural Body Solution” 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. 6. SERIOUSDRUG INTERACTIONS
  7. 7. INTERACTIONWITH ANTIDEPRESSANTS
  8. 8. INTERACTIONWITH NSAIDS
  9. 9. INTERACTIONWI DECONGESTANT
  10. 10. INTERACTIONWITH CYP3A4INHIBITORS
  11. 11. FDAWARNINGS• 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. 12. FDAWARNING  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/safetyalertsfor
  13. 13. REFERENCES  http://www.fda.gov/Drugs/ResourcesForYou/Co  http://www.micromedexsolutions.c om CURRENT Diagnosis & Treatment: Gastroenterology, Hepatology, & Endoscopy, 2e Norton 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 of Internal Medicine, 18e  Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor
  14. 14. 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/Sibu tramineOct2010.asp  http://www.bmj.com/content/340/bmj.c824

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