Reductil Banned In Europe
(Was the suspension
of Reductil in Europe Justified?)
Ban of Reductil in
Europe, Reductil also known as Sibutramine after the
active ingredient in Reductil has been banned in Europe!
Actually, Reductil Banned or Ban of Reductil is not a
correct statement - Reductil has been suspended in Europe is the proper
description. Although a subtle difference Reductil has
only been suspended in Europe and not formally banned from
Europe.
 Whether
you are a healthcare professional, individual taking
Reductil or someone interested in taking Reductil in the
near future.
Please invest a few minutes of your time to read the
following that accurately addresses the decision to
suspend Reductil throughout Europe.
Free Strong Appetite
Suppressant Offer
(See below for more
information.)
 Why
was Reductil banned in Europe or suspended in Europe? Unfortunately, for some 86,000 obese
individuals, the European Medicines Agency (EMA)
requested that doctors stop prescribing Reductil (sibutramine)
while telling pharmacist not to dispense the
prescription weight loss pill, Friday January 22,
2010.
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Get the latest Reductil suspension news. Be the first to know when
the Reductil suspension is reversed and Reductil is available in
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Reductil Alternative
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Pressed for time, just want to know which appetite suppressants
doctors are now recommending since the suspension?
Doctors are now prescribing Physicians Select Appetite
Suppressants. One dose will suppress your appetite for up to 4-6
hours (click here for details).
Difficult to Understand Why Reductil Was Suspended
(Even modest weight loss has proven to
beneficial.)
Recent studies noted in prestigious
New England Journal of Medical show that even a modest weight loss
as a result of Reductil or other diet aids can significantly
reduce the following life-risk factors:
- Reduction of blood glucose
levels (decreasing the risk of diabetes).br>
- Lowering of diastolic and
systolic blood pressure (decreasing the risk of heart disease
and strokes).
- Reduction in blood cholesterol
levels (decreasing the risk of heart disease and strokes).
- Reduction of blood levels of
uric acid (decreasing the risk of gout).
- Reduction in the cases of sleep
apnea (irregular breathing during sleep).
- Weight reduction is also likely
to improve appearance, which has a positive affect on
self-esteem and motivation.
These same studies confirm
that if an overweight individual can lose just 10 percent of their
body weight they will reduce the stress on their cardiovascular
system by 90 percent.
This represents an outstanding
statistic that equates to reducing the risk of heart attacks by
90% in obese individuals.
Please review
below why the EMA was compelled to suspend Reductil:
Some 86,000 individuals in Europe were prescribed
Reductil (sibutramine) last year in an effort to assist
these individuals reach their weight loss goals. Some
eighty five percent of these individuals, that were
prescribed Reductil last year, want to know why Reductil
was suspended throughout Europe.
So Why
The Suspension of Reductil?
(Both GP's and patients are questioning the
suspension of Reductil.)
In
multiple respected clinical trials involving Reductil,
the prescription weight loss drug proved to be
effective. Combining Reductil with lifestyle changes
resulted significantly more weight loss when compared to
those individuals taking a placebo (sugar pill).
More importantly, there was a three to four fold
increase in the number of participants who lost
5–10% of their body weight while taking Reductil verses
a placebo (sugar pill).
But what about the SCOUT study that attempted to
prove that Reductil would increases the risk of
cardiovascular disease when taken for a period of five
years?
Do not jump to conclusions too fast prior to reviewing
the results of the SCOUT study. Most healthcare
professionals believe the results of the SCOUT study to
be credible, however, irrelevant to the population in
which Reductil is prescribed.
Quoted from the abstract of the SCOUT study.
"The Sibutramine
Cardiovascular Outcome Trial (SCOUT)
has been designed to determine
whether
weight management in
cardiovascular high-risk overweight and obese
patients can impact upon cardiovascular endpoints."
Please Note:
Sibutramine is the active ingredient in Reductil,
hence, the Sibutramine
Cardiovascular Outcome Trial (SCOUT)
study.
Compromised participants in the SCOUT study -
some 90% of the 10,000 plus participants in the SCOUT
study were selected only if they met the following
criteria:
- All Participants must be considered
obese.
- All Participants must have either
type 2 diabetes, dyslipidaemia (abnormal levels of fat in the
blood), and/or a history of coronary artery disease , peripheral
vascular disease, stoke or other cardiovascular risk factors.
- All participants must be
over 55 years of age.
Concerning the SCOUT Study
Results
(Risks of developing further
cardiovascular complications in an compromised
population.)
The
adjacent findings were in a compromised medical
population (individuals with heart disease or type 2
diabetes, as well as, one additional risk factor for
heart disease).
Another
major contributing factor that questions the validity of
the SCOUT study is patients were prescribed Reductil for
a period of five years when the guidelines for
prescribing Reductil specifically state that Reductil
should not be prescribed for longer than twelve months.
Many healthcare professionals are questioning whether
the results of the SCOUT study are significant?
Since the study only involved high risk patients with
pre-existing cardiovascular disease. In addition, the
Reductil in the SCOUT study was prescribe for five years
when all the recommendations for Reductil state "Reductil
should be prescribed for no longer than 12 months".
Reported "cardiovascular events" occurred in 1.4% of the
high risk population (11.4% taking Reductil minus 10%
taking a sugar pill).
Again, the above findings were in a
compromised medical population (individuals with heart disease or type
2 diabetes, as well as, one additional risk factor for heart disease)
that were prescribed Reductil for a duration of time that exceeded
five times the recommended time period. For these reasons healthcare
professionals are questioning the results of the SCOUT study or how
they pertain to the population in which Reductil is prescribed.
However,
regardless that negative results were found only in the above
mentioned high risk population. The study prompted both the EMA and
the Medicines and Healthcare products Regulatory Agency MHRA to
suspend Reductil across Europe.
What is the Advice of
the EMA and MHRA Following the Suspension of Reductil
(Alternative treatments, what if there are no similar
alternative treatments?)
Following the ban on
Reductil in Europe both the European Medicines Agency (EMA) and
The Medicines and Healthcare products Regulatory Agency MHRA
reportedly gave these recommendations:
"Users of Reductil should not worry and should arrange to see their
family doctor to be put on an alternative treatment. "
--- The Challenge With Their
Advice - there is no "alternative
treatment" in the same class of prescription weight loss pills as
Reductil. Unfortunately, Reductil is the only prescription appetite
suppressant available in Europe. Therefore, the recommended
"alternative treatment" is not going to be a strong prescription
appetite suppressant similar to Reductil. Doctors will have to educate there
patients with regards to counting calories, exercising while
prescribing Xenical a prescription fat. blocker.
Effective Weight Loss
Alternatives to Reductil
(Doctors are recommending
Physicians Select Appetite Suppressants and Xenical.) Physicians Select Appetite
Suppressant -- The Strongest Appetite
Suppressant Available!
Doctors are also prescribing
Physicians' Select Appetite Suppressants. Secondary to
the suspension of Reductil, Physicians' Select Appetite
Suppressants now represents the strongest appetite
suppressant available in Europe.
"Although we have always had
strong sales of the Physicians' Select Appetite
Suppressants our sales over the last two weeks have more
than tripled. The amazing note is the that some 85% of our clients
are requesting repeat orders, which is the best indication that the
appetite suppressants are working."
-------- James M Pringle, M.D.
More doctors are now recommending
Physicians' Select Appetite Suppressants than any other
weight loss product.
Free Appetite Suppressant
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Xenical - The Only Prescription Fat Blocker!
The
only prescription weight loss pill now available in Europe following the ban of
Reductil is Xenical, manufactured by Roche pharmaceuticals. Fortunately, Xenical
is a very effective weight loss drug. Xenical is the only prescription "fat
blocker" that actually blocks 1/3 of all calories consumed in your diet from
being absorbed.
However, secondary to the ban on Reductil there
are now serious concerns with regards to the available supply of the
already popular prescription Xenical diet pill. (for additional
information concerning Xenical (click here for details).
Does The SCOUT Study
Assist Doctors Prescribing Reductil?
(GP's do not prescribe Reductil to individuals with pre-existing
cardiovascular risk factors.)
From
my point of view, a licensed doctor, the results from the SCOUT
study do not reflect the demographics of the patient who we prescribe
Reductil. The population studied in the SCOUT study all had
increased risk factors for cardiovascular disease. Again, individuals
with medical histories similar to those individuals followed in the
SCOUT study are not prescribed Reductil by responsible doctors.
In addition, according to the guidelines
set forth for prescribing Reductil the medication should be prescribed
for no longer than the recommended twelve month period. However, in
the SCOUT study participants were prescribed Reductil for five years
(five times longer than recommended).
Strict Recommendations
Doctors Follow When Prescribing Reductil
(The guidelines protect patients with pre-existing
cardiovascular risks).
So
you can understand why the results of the SCOUT study do not pertain
to the patients in which doctors would actually prescribe Reductil.
Please review the following guidelines set forth for doctors in order
to safely prescribe Reductil to their patients.
These strict guidelines, unlike those in
the SCOUT study, protect individuals with pre-existing
cardiovascular risks from receiving a prescription for Reductil.
In order to protect individuals with a pre-existing cardiovascular
history, doctors following the following guidelines prior to
prescribing Reductil:
- History of coronary
artery disease (myocardial infarction, angina)
- History of heart arrhythmias.
- History of congestive heart
failure.
- History of peripheral arterial
disease.
- Uncontrolled
hypertension (eg, >145/90 mm Hg).
- History of stroke or transient
ischemic attack.
Trying to Understand The Suspension of Reductil
(Both the EMA and MHRA have an excellent record with
regards to your best health interest.)
Over the years the MHRA and the
EMA have proven to use sound judgment protecting the citizens of
Europe's health.
However, with those accolades in place and
the utmost respect for their judgment (by both healthcare
professionals and the general public) individuals cannot help but
question their decision to suspend Reductil throughout Europe. This
question still needs to be addressed:
Was the decision to suspend Reductil in Europe made prematurely?
Especially when we know that 90% of the 10,000 participants
in the SCOUT study had the following pre-existing medical conditions:
- All Participants must be considered
obese.
- All Participants must have either
type 2 diabetes and/or a history of coronary artery disease ,
peripheral vascular disease, stoke or other cardiovascular risk
factors.
- All participants must be over 55 years of
age.
As well as, the fact that the Reductil was
prescribed for a duration five times longer in the SCOUT study than
recommended.
The U.S. Food and Drug Administration (FDA) will continue to review
findings from the SCOUT study, which was designed to test whether
Reductil could help prevent heart problems by helping overweight
individuals lose weight.
The FDA isn't making any conclusions about the early findings at this
time. Analysis of the study's findings is ongoing.
The FDA will
continue to review findings from the SCOUT study, which was designed
to test whether Reductil could help prevent heart problems by helping
overweight and obese people lose weight. The FDA isn't making any
conclusions about the early findings at this time. Analysis of the
study's findings is ongoing.
Interesting Point
- the FDA has been very conservative
over the last two decades especially with regards to prescription
weight loss drugs. The FDA has not banned Reductil following the
release of the SCOUT study, however, the FDA did issue the following
statement to reiterate doctors should not
prescribe Reductil to individuals with pre-existing cardiovascular
risk factors:
"The preliminary study findings highlight the importance
of avoiding the use of Reductil in patients with a history of coronary
artery disease (heart disease), congestive heart failure (CHF),
arrhythmias, or stroke, as recommended in the current Reductil
labeling."
False Reports
Australia Banned Reductil
(Australia
issues same recommendations as the FDA)
Just recently, there were false reports that Reductil had been
banned in Australia. When in fact, Abbott with full cooperation of the
Australian Therapeutic Goods Administration had just sent a reference
letter to doctors with regards to changes in the Reductil product
labeling
According
to a spokesman from Abbott the letter sent to the doctors contained
information that Reductil should not be prescribed to patients with
pre-existing cardiovascular risks.
The
Manufactures Opinion of the Suspension of Reductil
(Abbott contends that the SCOUT study does not address the
population taking Reductil.)
A
spokesman for Abbott Laboratories, the manufacture of Reductil, states
the prescription medication is safe when used in the appropriate group
of people, as prescribed. According to Kurt Ebenhoch, the SCOUT study
looked at high-risk patients who took the drug much longer than the
one-year maximum use that is recommended.
According to Kurt
Ebenhoch, an Abbott spokesperson:
"Reductil
is not recommended or approved for use in more than 90%
of the patients in the SCOUT study,"
Eugene Sun, vice president of Abbott's Global
Pharmaceutical Research and Development department, said: "We
believe there are many patients who benefit from Reductil and
respectfully disagree with the committee's opinion and the
recommendation to suspend the medicine.
"However, we will act promptly to comply with the committee's
recommendation."
National Obesity Forum Opinion of the
Suspension of Reductil
(Suspension of
Reductil is disappointing for many obese individuals who were losing
weight.)
The National Obesity Forum (NOF) was established by
healthcare professionals in May 2000 to increase the
awareness of the growing health impact that being obese
is having on patients, as well as, The National Health
Service (NHS).
In
fact,
Dr
David
Haslam, The Chairman of
the National Obesity Forum
said he was very surprised by the
decision
to ban
Reductil and issued the
following statements:
"It is
disappointing to see a drug that doctors had been using
effectively for almost a decade was being suspended at a
time when the nation was experiencing an "obesity
epidemic".
Prof Haslam
said the European trial had been examining the impact of
the drug on people with heart problems, and he believed
that, because some of the test results had shown it had
a negative effect on their health, the effects were
being extrapolated to all other users.
He added: "We
are going to have to look at this closely. It will mean
taking thousands of people off this drug and then
managing the negative effects that come with weight
regain. It's a step that needs to be taken with great
care.
"You have to look at the health
benefits against the risks," he said. "Anything has a
potential risk – paracetamol, aspirin – but you have to
see if the benefits outweigh the risks."
How Reductil
Allows Individuals to Lose Weight
(Reductil
with diet and exercise will assist individuals lose weight.)
Reductil
is a serotonin and norepinephrine reuptake inhibitor approved for
the management of obesity. Reductil acts centrally in the brain as
effective appetite suppressant, that allows you to overcome the
biggest barrier to losing weight, a strong appetite.
Reductil signals an area in the brain so you feel full and
eat less. Reductil also prevents a fall in your metabolic rate that
is often associated with weight loss.
