fda's notification on "lite fit usa"
DESCRIPTION
On 10th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Lite Fit USA” which is promoted and sold for weight loss on various websites including www.herbsultimate.com, and in some retail stores.TRANSCRIPT
FDA’s Notification FDA’s Notification on on “Lite Fit USA” “Lite Fit USA”
Dr. P.Naina MohamedDr. P.Naina Mohamed
PharmacologistPharmacologist
Intr
oduct
ion
Intr
oduct
ion
On 10On 10 thth Apr 2014, the Food
Apr 2014, the Food
and Drug Administration
and Drug Administration
(FDA) is advising consumers
(FDA) is advising consumers
not to purchase or use
not to purchase or use “Lite “Lite
Fit USA”.Fit USA”.““Lite Fit USA”
Lite Fit USA” is promoted
is promoted
and sold for weight loss and
and sold for weight loss and
sold on various websites
sold on various websites
including www.herbsultimate.com and and
in some retail stores.
in some retail stores.
FDA laboratory analysis
FDA laboratory analysis
confirmed that
confirmed that “Lite Fit “Lite Fit
USA” USA” contains
contains Sibutramine.
Sibutramine.
Sibutramine is a controlled
Sibutramine is a controlled
substance and it was removed
substance and it was removed
from the market in October
from the market in October
2010 for safety reasons.
2010 for safety reasons.
Poss
ible
Po
ssib
le
Mech
anis
m o
f
Mech
anis
m o
f act
ion
act
ion
Ris
ks o
f R
isks
of Li
te F
it
Lite
Fit
U
SA
USA
Contr
ain
dic
ati
ons
Contr
ain
dic
ati
ons
of
Lite
Fit
USA
of
Lite
Fit
USA
(Sib
utr
am
ine)
(Sib
utr
am
ine)
Lite Fit USA” should not be used by the
Lite Fit USA” should not be used by the
patient who has …
patient who has …History of cerebrovascular
History of cerebrovascular
disease (stroke or transient
disease (stroke or transient
ischemic attack)
ischemic attack)History of congestive heart failure
History of congestive heart failure
History of coronary artery disease
History of coronary artery disease
(eg, angina, myocardial
(eg, angina, myocardial
infarction)infarction)History of cardiac arrhythmias
History of cardiac arrhythmias
History of peripheral arterial
History of peripheral arterial
occlusive disease
occlusive diseaseUncontrolled hypertension.
Uncontrolled hypertension.
Major eating disorders, major (eg,
Major eating disorders, major (eg,
anorexia nervosa or bulimia
anorexia nervosa or bulimia
nervosa)nervosa)Concomitant use with MAOIs
Concomitant use with MAOIs
Concomitant use with other
Concomitant use with other
centrally acting weight loss drugs
centrally acting weight loss drugs
Seri
ous
Dru
g
Seri
ous
Dru
g
Inte
ract
ions
Inte
ract
ions
Inte
ract
ion w
ith
Inte
ract
ion w
ith
Anti
depre
ssants
Anti
depre
ssants
Inte
ract
ion w
ith
Inte
ract
ion w
ith
NSA
IDs
NSA
IDs
Inte
ract
ion w
ith
Inte
ract
ion w
ith
Deco
ngest
ants
Deco
ngest
ants
Inte
ract
ion w
ith
Inte
ract
ion w
ith
CYP3A
4 Inhib
itors
CYP3A
4 Inhib
itors
FDA
FD
A
Warn
ings
Warn
ings
• FDA warns the Consumers should
FDA warns the Consumers should
stop using this product
stop using this product
immediately and throw it away.
immediately and throw it away.
• FDA advises the Consumers who
FDA advises the Consumers who
have experienced any negative
have experienced any negative
side effects should consult a
side effects should consult a
health care professional as soon
health care professional as soon
as possible.
as possible. • FDA announces to the public of a
FDA announces to the public of a
growing trend of dietary
growing trend of dietary
supplements or conventional
supplements or conventional
foods with hidden drugs and
foods with hidden drugs and
chemicals. These products are
chemicals. These products are
typically promoted for sexual
typically promoted for sexual
enhancement, weight loss, and
enhancement, weight loss, and
body building, and are often
body building, and are often
represented as being “all
represented as being “all
natural.” natural.” • FDA claims that they are unable
FDA claims that they are unable
to test and identify all products
to test and identify all products
marketed as dietary supplements
marketed as dietary supplements
on the market that have
on the market that have
potentially harmful hidden
potentially harmful hidden
ingredients.
ingredients. • FDA advises the Consumers to
FDA advises the Consumers to
exercise caution before
exercise caution before
purchasing any product in the
purchasing any product in the
above categories.
above categories.
FDA
FD
A
Warn
ings
Warn
ings
FDA has requested market withdrawal
FDA has requested market withdrawal
after reviewing data from the
after reviewing data from the
Sibutramine Cardiovascular Outcomes
Sibutramine Cardiovascular Outcomes
Trial (SCOUT).
Trial (SCOUT). SCOUT is part of a postmarket
SCOUT is part of a postmarket
requirement to look at cardiovascular
requirement to look at cardiovascular
safety of sibutramine after the
safety of sibutramine after the
European approval of the drug.
European approval of the drug.
The trial demonstrated a 16 percent
The trial demonstrated a 16 percent
increase in the risk of serious heart
increase in the risk of serious heart
events, including non-fatal heart attack,
events, including non-fatal heart attack,
non-fatal stroke, the need to be
non-fatal stroke, the need to be
resuscitated once the heart stopped,
resuscitated once the heart stopped,
and death, in a group of patients given
and death, in a group of patients given
sibutramine compared with another
sibutramine compared with another
given placebo.
given placebo. There was a small difference in weight
There was a small difference in weight
loss between the placebo group and the
loss between the placebo group and the
group that received sibutramine.
group that received sibutramine.
RECOMMENDATION
RECOMMENDATION: Physicians are
: Physicians are
advised to stop prescribing Sibutramine
advised to stop prescribing Sibutramine
(Meridia) to their patients, and patients
(Meridia) to their patients, and patients
should stop taking this medication.
should stop taking this medication.
Patients should talk to their health care
Patients should talk to their health care
provider about alternative weight loss
provider about alternative weight loss
and weight loss maintenance programs.
and weight loss maintenance programs.
http://www.fda.gov/safety/medwatch/safet
yinformation/safetyalertsforhumanmedical
products/ucm228830.htm
Refe
rence
sRefe
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http://www.fda.gov/Drugs/
www.fda.gov/Drugs/
ResourcesForYou/
ResourcesForYou/
Consumers/
Consumers/BuyingUsingMedicineSafely/
BuyingUsingMedicineSafely/
MedicationHealthFraud/
MedicationHealthFraud/
ucm392810.htm?
ucm392810.htm?
source=govdelivery&utm_me
source=govdelivery&utm_me
dium=email&utm_source=gov
dium=email&utm_source=gov
deliverydeliveryhttp://http://www.micromedexsolutions.co
www.micromedexsolutions.co
mmCURRENT Diagnosis &
CURRENT Diagnosis &
Treatment: Gastroenterology,
Treatment: Gastroenterology,
Hepatology, & Endoscopy, 2e
Hepatology, & Endoscopy, 2e
Norton J. Greenberger, Richard S.
Norton J. Greenberger, Richard S.
Blumberg, Robert Burakoff
Blumberg, Robert Burakoff
Clinician's Pocket Reference,
Clinician's Pocket Reference,
11e11eLeonard G. Gomella, Steven A.
Leonard G. Gomella, Steven A.
Haist Haist Harrison's Online
Harrison's Online
Featuring the complete contents
Featuring the complete contents
of of Harrison's Principles of
Harrison's Principles of
Internal Medicine, 18e
Internal Medicine, 18e
Basic & Clinical
Basic & Clinical
Pharmacology, 12e
Pharmacology, 12e
Bertram G. Katzung, Susan B.
Bertram G. Katzung, Susan B.
Masters, Anthony J. Trevor
Masters, Anthony J. Trevor
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http://www.fda.gov/
http://www.fda.gov/
safety/medwatch/
safety/medwatch/safetyinformation/
safetyinformation/safetyalertsforhumanmed
safetyalertsforhumanmed
icalproducts/
icalproducts/ucm228830.htm
ucm228830.htm http://www.tga.gov.au/
http://www.tga.gov.au/
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http://http://www.medsafe.govt.nz/
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http://www.bmj.com/
http://www.bmj.com/
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