Octagam to return to Oz
August 29, 2011
THE Therapeutic Goods
Administration has announced the
lifting of a voluntary recall of all
batches of Octapharma Australia’s
Octagam 5%.
The recall took place in September
last year after the discovery of an
increased incidence of
thromboembolic complications
associated with the use of the
immunodeficiency treatment in
Europe and the USA.
Subsequent investigations into
the thromboembolic events
uncovered a link between the to
manufacturing issues, including
increased levels of Factor XIa, an
actived coagulation factor that is
involved in thrombus formation.
According to the company, the
manufacturing issues have since
been addressed, with solutions
including changes to processes
that have lowered the levels of
Factor XIa to acceptable levels.
In addition Octapharma has
introduced additional testing of the
final product to prevent batches
with elevated thrombogenic
potential from being released to
the market.
The new Octagam 5% batch is
now set to be independently
tested by European Official
Medicines Control Laboratories,
and the issued certificate will be
inspected by the TGA before a new
batch is released in Australia.
Additional re-supply conditions
from the TGA to Octapharma also
include the stipulation that all
batches of Octagam released for
supply in Australia will be
approved by the TGA and that the
company must implement a Risk
Management Plan that includes
post marketing safety studies and
the provision of updated information
to healthcare professionals and
professional bodies.
The TGA has allowed the resupply
of Octagam 5% since 08 Aug.
At present, a similar ban on the
company’s Octagam 10% has not
been lifted as the corrective
manufacturing changes for this
strength have not yet been
reviewed by the TGA.
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