Remove diclofenac from EML?
February 18, 2013
DICLOFENAC should be removed
from national Essential Medicines
Lists (EMLs) and its marketing
authorisations should be revoked
globally, according to research
published in PLoS Medicine.
The study looked at the extent to
which evidence on cardiovascular
risk with NSAIDs has translated into
guidance and sales in 15 countries.
In doing so the study took into
account meta-analyses of
randomised trials and controlled
observational studies, and obtained
the list of individual NSAIDs on
Essential Medicines Lists from the
World Health Organisation.
In addition, NSAID sales or
prescription data for 15 low-,
middle-, and high-income countries
was obtained from Intercontinental
Medical Statistics Health (IMS
Health) or (in the case of England
and Canada) the national
prescription pricing audit.
According to the study findings,
three drugs: rofecoxib, diclofenac,
etoricoxib, were ranked
consistently highest in terms of
cardiovascular risk compared with
nonuse, whilst naproxen was
associated with a low risk.
Interestingly diclofenac and
etoricoxib accounted for one-third
of total NSAID usage across the 15
countries, with diclofenac the most
commonly used- taking an average
market share of 30%, despite its
higher relative risk of
cardiovascular events.
In contrast, researchers noted
that naproxen, which was found to
be one of the safest NSAIDs
examined, was among the least
popular and was listed on a
minority of EMLs.
“Listing of NSAIDs on national
EMLs should take account of
cardiovascular risk, with preference
given to low risk drugs,” the
researchers said.
“Diclofenac has a risk very similar
to rofecoxib, which was withdrawn
from worldwide markets owing to
cardiovascular toxicity.
“Diclofenac should be removed
from EMLs,” the researchers
added.
MEANWHILE ASMI has urged
caution in interpreting the research
results, noting that no new data on
cardiovascular risk had been
included in the analysis and, that
the analysis did not segregate
prescription and over-the-counter
(OTC) NSAID data.
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