NSAIDs under fire, again
November 8, 2011
A RECENT article in The Medical
Journal of Australia has once again
ignited debate over the safety
profile of non-steroidal antiinflammatory
drugs (NSAIDs).
The article titled Stroke risk and
NSAIDs: an Australian populationbased
study, looked at the risk of
stroke associated with nonsteroidal
anti-inflammatory drug
use, and found that patients
prescribed with NSAIDs saw an
associated increased risk of stroke.
The study looked at 162,065
Australian veterans with incident
dispensing of an NSAID between
01 Jan 2001 and 31 Dec 2008 and
their rates of hospitalisation for
stroke, ischaemic stroke or
haemorrhagic stroke.
According to the study the
incident use of NSAIDs was
associated with a 1.88 times
increased risk of hospitalisation for
stroke (ischaemic or
haemorrhagic) following first ever
dispensing of an NSAID.
“Increased awareness of the
potential for serious adverse
cardiovascular events, together
with individual assessment of
cardiovascular risk, careful
deliberation of the balance
between risk and benefits and
appropriate supervision, is required
when initiating NSAID therapy,” the
authors said.
Aiming to alleviate concerns over
Voltaren, Novartis issued a
statement saying diclofenac
therapies were not assessed in the
study and that it is confident about
the safety profile of the drugs.
“Voltaren (diclofenac)
medications are available worldwide
and have been used by
millions of patients for more than
30 years, making it one of the
world’s most widely-used pain
relieving and anti-inflammatory
medicines,” the company said.
“Medical evaluation of
postmarketing data has not
identified any new cardiovascular
safety trend...The data reported in
the Caughey study is in line with
the known cardiovascular safety
profile,” the statement added.
In relation to the study itself
Novartis was quick to point out that
the authors stated “the analysis is
associative only and does not
prove causality”.
MEANWHILE ASMI has also
joined the chorus of NSAID
defence, saying that current label
warnings and existing advice
regarding the non-prescription use
of NSAIDs remains sound.
“This study did not examine
lower non-prescription doses or
over-the-counter (OTC) use of
NSAIDs, and was conducted in a
very specific study population,”
said ASMI Regulatory and Scientific
Affairs Director, Steven Scarff.
“Many of the veterans studied
suffer from a range of medical
conditions and will, on average, be
prescribed 11 unique medicines in
a year,” Scarff added.
In addition, Scarff added that
whilst the authors were unable to
examine the OTC use of NSAIDs,
they found no association between
ibuprofen use and an increased
risk of stroke in this specific
population.
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