chemxpert

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Nimesulide I have every sympathy with K
Weerasuriya's final sentiment (June 19, p 2162)1
that health should come before trade and that
rapid registration of new drugs should not be at
the expense of proper evaluation. However, I must
make two comments about the particular example
Weerasuriya chose, the anti-inflammatory,
nimesulide
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Nimesulide is described as a selective inhibitor
of cyclo-oxygenase-2 (COX-2) in the same sentence
as it is given as a cause of fulminant hepatic
failure. Nimesulide is not a selective COX-2
inhibitor, compared with the two recently
introduced selective COX-2 inhibitors, celecoxib,
and rofecoxib that have inhibitor selectivities
well in excess of that of nimesulide.
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Thus, any correlation between COX-2 inhibition
and hepatic injury which could easily be inferred
from Weerasuriya's sentence, would be entirely
unjustified. A fear of hepatic injury from these
new compounds could dissuade many patients with
rheumatoid arthritis or osteoarthritis and their
prescribers from a much greater possibility of
real clinical benefit.
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Weerasuriya's treatment of nimesulide is unfair.
It is not a me-too non-steroidal
anti-inflammatory drug (NSAID). This compound
exhibits significant clinical differences from
other NSAIDs.4 For example, nimesulide has been
used successfully in aspirin-sensitive asthmatics
and in premature labour, disorders in which other
NSAIDs are not tolerated.
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The cases of hepatic failure should be balanced
against the long and successful experience with
nimesulide in many European and South American
countries.I agree there is no substitute for a
proper examination of the data offered in support
of any candidate for drug registration and it is
not enough to rely on the simple fact of
registration in other countries.
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But it is also illogical to rely on the lack of
registration or on isolated reports of toxicities
or on difficulties that may be resolved by
written changes in the summary of product
characteristics,5 as a basis for rejection.
Finally, let me assure you I am not a consultant
for any of the many sellers of nimesulide,
celecoxib, or rofecoxib.
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