ASMI defends NSAID safety
January 13, 2011
OVER the counter non-steroidal
anti-inflammatory drugs (NSAIDs)
are safe and effective for the
temporary relief of pain and
inflammation, according to The
Australian Self-Medication
Industry.
The comment comes in response
to a recent meta-analysis study
published in the British Medical
Journal (BMJ 2011; 342:c7086)
which analysed all the available
evidence relating to the
cardiovascular safety of NSAIDs.
Study investigators looked at the
results of 31 large scale
randomised controlled trials,
involving a total of 116,429
patients, which compared NSAIDs
with non-steroidal drugs or
placebos, and concluded that
“although uncertainty remains,
little evidence exists to suggest that
any of the investigated drugs are
safe in cardiovascular terms”.
NSAID drugs investigated in the
trials included naproxen,
ibuprofen, diclofenac, celecoxib,
etoricoxib, rofecoxib, and
lumiracoxib, with results varying as
to their cardiovascular risk profile.
Analysts found that rofecoxib
was associated with the highest
risk of myocardial infarction, whilst
ibuprofen exposed patients to the
highest risk of stroke, and the
highest rates of cardiovascular
deaths were linked to etoricoxib
and diclofenac.
Responding to the results, ASMI
urged both healthcare
professionals and the public to
“take care” in interpreting the
study’s conclusions, adding that
studies included in the analysis
involved high (prescription) doses
and long-term treatment of
chronic conditions.
“It is important that the results of
this study and the conclusions
drawn by its authors are not
confused with the safety profiles of
OTC NSAIDs available in Australia,”
ASMI said in a statement.
“OTC NSAIDs such as ibuprofen,
naproxen and diclofenac, are
approved by the Therapeutic
Goods Administration (TGA) for
short-term use at low doses for
self-limiting conditions.
“The lower doses of OTC
NSAIDs and their short term use
mean that their safety profiles are
different to their higher dose,
prescription counterparts.” the
statement added.
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