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HEALTH ALERT
October 8th 2010
Sibutramine (Reductil) – Withdrawal in Australia
Following discussions with the Therapeutic Goods Administration (TGA), Abbott
Australasia will cease supply of sibutramine (Reductil) in Australia
from 9 October
2010. Sibutramine, marketed in Australia as Reductil, is a prescription medicine
indicated for weight loss.
These regulatory actions follow an analysis of the results of a major study known as
the Sibutramine Cardiovascular OUTcomes (SCOUT) study, which showed a higher
rate of cardiovascular events in obese and overweight patients using sibutramine
than in patients managing their weight through exercise and diet alone.
Preliminary results of the SCOUT study were first released in late 2009 / early 2010.
In response to the preliminary findings, and pending an analysis of the final study
results, the TGA reinforced existing advice in the sibutramine Australian approved
Product Information (PI), shortening the maximal duration of therapy and
strengthening the criteria for ceasing treatment.
These amendments were communicated in letters to medical practitioners, through
safety advisory statements on the TGA webpage and through the June 2010 edition
of the TGA’s Medicines Safety Update.
At the time the preliminary results of the SCOUT study became available, the
Australian Product Information
already contained precautionary information about
use of sibutramine in patients with a history of heart attack and stroke.
Analysis of the final results of the SCOUT study have since confirmed there is an
increased in risk of major cardiac events such as heart attack and stroke in obese
and overweight patients taking sibutramine. Furthermore, the increased risk 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 Product Information, it remains unclear whether the
safety of sibutramine is acceptable even in those who respond to the medicine
Any patients currently taking sibutramine who have concerns should discuss these
with their treating practitioner.
Media contact: TGA Media Unit 02 6289 7400
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