On 10th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Infinity” which is promoted and sold for weight loss on various websites, and in some retail stores.
Dr. P.NaiNa MohaMeD
Apr 2014, the Food and Drug
Administration (FDA) is advising consumers
not to purchase or use “Infinity”.
“Infinity” is promoted and sold for weight loss
and sold on various websites and in some
FDA laboratory analysis confirmed that
“Infinity” contains Sibutramine.
Sibutramine is a controlled substance and it
was removed from the market in October
2010 for safety reasons.
Contraindications of Infinity
“Infinity” 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,
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
• 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).
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.
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