TGA Medicines Safety update
April 6, 2016
THE Therapeutic Goods
Administration has provided its
latest Medicines Safety Update
with a summary of changes to date
around medicine naming policies.
A number of medicine ingredient
names are being changed to align
with names used internationally
as part of an international
harmonisation program announced
last year (PD 25 Nov 15).
The four year transition period
for the changes will run from now
until Apr 2020, with some changes
minor such as changing a ‘y’ to an
‘i’ and will not affect pronunciation.
More significant changes include
the treatment of adrenaline and
noradrenaline which will remain
as approved names in Australia,
with the international name
(epinephrine and norepinephrine
respectively) in brackets after the
name.
New ingredient names will start
to appear on medicine labels, in
product information and consumer
medicine information leaflets as
well as in dispensing software from
this month.
Pharmacists are asked to reassure
patients that only the name of the
ingredient has been changed, with
no alteration to the medicine’s
formulation, quality, safety or
efficacy.
The full list of affected ingredients
is online at www.tga.gov.au.
MEANWHILE other items covered
in the safety update include
Xgeva (denosumab) which is now
contradicted in patients with
unhealed lesions from dental or
oral surgery due to increased risk
of osteonecrosis of the jaw, with
the TGA saying it will work with the
sponsor to add this contradiction to
the Australian PI.
Erlotinib has a change in
indication restricting its use for
maintenance therapy to patients
with EGFR mutations only.
The PI for ibrutinib, which is
marketed in Australia as Imbruvica,
a selective and covalent inhibitor of
Bruton’s tyrosine kinase, has new
restrictions related to the product’s
tendency to hepatotoxicity, with
recommendations for intervention.
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