Abbott withdraws sibutramine
October 11, 2010
AUSTRALIAN pharmacists will
cease to receive any more supplies
of Abbott’s weight loss drug
Reductil (sibutramine) after the
manufacturer voluntarily withdrew
the therapy from the market.
The withdrawal follows close
consultation with the Therapeutic
Goods Administration, over the
final results of a major study titled
the Sibutramine Cardiovascular
OUTcomes (SCOUT) study.
The study, six years in the
making, involved 10,000
participants and was requested by
European regulatory authorities as
a post-marketing committment to
evaluate cardiovascular safety in
high-risk patients.
According to the study’s final
results, overweight and obese
patients taking sibutramine had a
higher rate of cardiovascular
events than patients who managed
their weight through diet and
exercise alone.
The study’s preliminary results,
released in November last year,
indicated a higher risk of
cardiovascular events in patients
taking sibutramine, and prompted
the TGA “reinforce its existing [PI]
advice” to shorten the maximum
duration of therapy and strengthen
the criteria for ceasing treatment,
pending the study’s final results.
Today, Abbott released a
statement contending that under
the current labelling and
prescription regulations, most of the
study’s participants would, in
Australia, have been ineligible to
receive Reductil.
“Sibutramine was approved in
Australia for weight loss in patients
who are either obese or overweight,
have no previous history of
cardiovascular disease and have
been unable to lose weight through
diet and exercise,” the statement
continued.
“Abbott’s evaluation of the
SCOUT study does not change its
assessment that sibutramine has a
positive benefit/risk profile when
used appropriately in the approved
patient population,” the statement
added.
The TGA has however posted
comment on its website saying that
“the increased risk [of
cardiovascular events in patients
taking the drug] is not significantly
different across various patient
subgroups in the study, including
the subgroup that most closely
approximates the approved use of
sibutramine in Australia.
“Although it has to some extent
been possible to address emergent
safety signals through
modifications to the PI, it remains
unclear whether the safety of
sibutramine is acceptable even in
those who respond to the
medicine,” the TGA added.
Patients in Australia currently
taking Reductil are now advised to
cease their usage and consult with
their GP over other weight-loss
avenues, and in turn GPs are also
being advised to stop issuing
prescriptions for the drug.
Abbott has also set up a toll free
number where patients and
healthcare professionals can seek
advice on 1800 225 311 - or by
visiting www.sibutramine.com/
Australia.
MEANWHILE following the
study’s final conclusions, the
European Medicines Agency has
also suspended its sibutramine
approval, and in the USA Abbott
has also agreed to voluntarily
withdraw its Meridia sibutramine
product.
“Meridia’s continued availability
is not justified when you compare
the very modest weight loss that
people achieve on this drug to their
risk of heart attack or stroke,” said
John Jenkins, director of the Office
of New Drugs in the FDA’s Center
for Drug Evaluation and Research.
“Physicians are advised to stop
prescribing 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,” he
added.
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