EMA to review ibuprofen
June 17, 2014
THE European Medicines
Agency’s (EMA) Pharmacovigilance
Risk Assessment Committee has
started a review to evaluate the
cardiovascular risks with systemic
ibuprofen medicines.
This followed the Committee’s
work examining the risks of other
non-steroidal anti-inflammatory
drugs (NSAIDs) and would look
at the cardiovascular risks of high
dose ibuprofen (2,400 mg per day)
taken regularly for long periods, it
said.
Ibuprofen was usually taken at
lower doses for short periods and
as such there was no suggestion of
similar cardiovascular risk as used
by most patients, the EMA said.
The review would also look at
evidence regarding the interaction
of ibuprofen with low-dose aspirin.
A spokesperson for the
Therapeutic Goods Administration
said it was in the process of
finalising a review of NSAIDs,
including ibuprofen, and their
association with cardiovascular
risk, which it expected to publish in
coming months.
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