fda's advice on natural body solution
DESCRIPTION
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.TRANSCRIPT
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 “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.
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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
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S• 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.
FDA
WA
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S 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/safetyalertsforhumanmedicalproducts/ucm228830.htm
REFE
REN
CES
http://www.fda.gov/Drugs/ResourcesF
orYou/Consumers/BuyingUsing
MedicineSafely/MedicationHealt
hFraud/ucm396061.htm?source
=govdelivery&utm_medium=e
mail&utm_source=govdelivery
http://www.micromedexsolutions.c
om 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
REFE
REN
CES
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