FDA’S ADVICE ON
Dr. P.Naina Mohamed
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 is a controlled substance and it was
removed from the market in October 2010 for
NATURAL BODY SOLUTION
“Natural Body Solution” should not be used by the
patient who has …
History of cerebrovascular disease (stroke or transient
History of congestive heart failure
History of coronary artery disease (eg, angina, myocardial
History of cardiac arrhythmias
History of peripheral arterial occlusive disease
Major eating disorders, major (eg, anorexia nervosa or
Concomitant use with MAOIs
Concomitant use with other centrally acting weight loss
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
• FDA advises the Consumers to exercise caution
before purchasing any product in the above
FDA has requested market withdrawal after reviewing data
from the Sibutramine Cardiovascular Outcomes Trial
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
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