Reductil Suspension In Europe
(Was the suspension of Reductil in Europe Justified?)
Reductil also known as
Sibutramine after the active ingredient in Reductil has been
suspended in Europe. What prompted the suspension of Reductil
in Europe.
Was this Reductil suspension
justified? What do medical professionals think about the
suspension of Reductil in Europe? What are their
recommendations, alternatives to Reductil?
Get the answers
to these questions and more below:
 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.)
 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. |
Get the latest Reductil suspension news.
Be the first to know when the Reductil
suspension is reversed and Reductil
is available in Europe again.
|
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.
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Pressed for time, just want to know which appetite suppressants
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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).
- 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.
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
(They recommend seeing your GP or doctor for effective alternative
treatments, see below:)
Following the
suspension of 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. "
Effective Weight
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Physicians
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Clinical studies suggest that using
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you to lose more weight than just dieting or dieting with just
Reductil. (Need more information? Read below:)
Physicians Select Appetite Suppressants
(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
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-------- James M Pringle, M.D.
More doctors are now recommending Physicians' Select Appetite
Suppressants than any other weight loss product.
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More doctors are now recommending Physicians'
Select Appetite Suppressants than any other weight loss product.
For more information concerning this strong appetite suppressant
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Xenical Fat
Blocker
(Xenical the only prescription
fat blocker.)
The
only prescription weight loss pill now available in Europe following
the suspension 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 suspension of 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 suspended 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 Suspended Reductil
(Australia issues same recommendations as the FDA)
Just recently, there were false reports that Reductil had been
suspended 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 suspend 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.
