Risperidone update
August 4, 2015
The Product Information
(PI) for risperidone has been
updated by the Therapeutic
Goods Administration, to limit the
indication in dementia and restrict
this use to short-term management.
Detailed in the TGA’s latest
Medicines Safety Update, there is
an increased risk of cerebrovascular
adverse events in dementia
patients taking risperidone.
Previously the drug was indicated
more generally for the treatment
of behavioural disturbances in
dementia, but is now limited to
a maximum of twelve weeks for
moderate to severe dementia only
of the Alzheimer type.
The safety update also details
changes to the PI for infliximab, to
provide further information about
the risk of skin cancers, particularly
in psoriasis patients who have
undergone phototherapy.
The TGA also reminded health
professionals that tramadol oral
drops are not approved for use in
children under the age of 12 years,
and no dosing instructions are
provided for this age group in the
Product Information.
Although there are 82 Tramadol
products on the ARTG, only one
of these, Tramal, has an oral drop
presentation, with the TGA saying
given the concentration (100mg/
mL) there’s a potential risk of
overdose in children.
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