Epidemic of encephalopathy by continuous use of NSAIDs is a drug disaster as large scale as those by thalidomide, SMON and blood-products-induced HIV
We have been studying and make some comments
about the risk of NSAIDs that are probably related with Reye's syndrome
(or severe type of influenza-related encephalopathy).
Risk is 13-50 times higher for getting RS or severe encephalopathy and 18 times higher for getting it and die.
 As for Reye's syndrome (definite or clinically
diagnosed Reye's syndrome), one of the results in the report of the
studies by the task force of MHW in 1990-1992 (reported in 1994) showed
that NSAIDs use is estimated 18 times higher for getting encephalopathy
and dying (the probability of mistaking saying so is below one in 1000:
i.e. p<0.001 in statistical term).
The report by the task force shows that investigators were aware of the risk
 The report for 1993 (made in 1995) described that
mefenamic acid and diclofenac was more frequently used in definite or
clinically diagnosed Reye's syndrome: among 32, 9 (28.1 %) used mefenamic
acid and 3 (9.4 %) used diclofenac, 12 (37.5 %) took either of the two,
while among 19 patients with encephalopathy other than Reye's syndrome
used neither of the two. The investigator described this data and
commented especially mefenamic acid, "it should be
At least eight individual results showed the close association
Thus by 1998, at least six individual study showed close association between Reye's syndrome or severe flu-related encephalopathy and NSAIDs. By including two studies done in 1999 and in 2000, the number of the studies that showed the close association between them is at least eight. Thus none should say that NSAIDs use is only the promoting factor of the severity of encephalopathy and not the cause inducing Reye's syndrome or severe encephalopathy. We have to think that NSAIDs is working at the point inducing Reye's syndrome or severe encephalopathy. So it is very important not to use NSAIDs as antipyretics to lower the body temperature in the infection including flu or common cold.
Ignoring the risk of NSAIDs is the matter of responsibility
The first warnings should be made for the risk of
the NSAIDs use in March 1994 at the latest when the report of task force
for 1990 to 1992 made. And at the latest the measure "to suspend using
NSAIDs" should be taken at March 1995 when almost definite data indicating
NSAIDs as the major risk factor inducing Reye's syndrome were collected.
If warnings had been issued in 1994, at least a half hundred lives might
be saved every year and more than a hundred sufferers of sequelae of
severe encephalopathy might be prevented.
A drug disaster as large scale as those by thalidomide, SMON and blood-products-induced HIV
We would like to point out that misestimating the
results of the studies and delay of taking measures by the Pharmaceutical
and Medical Safety Bureau in MHW have been producing a new drug disaster
as large scale as that by thalidomide, SMON and blood-products-induced
Drug industries producing NSAIDs should change labeling by adding the contraindication for the use as antipyretics.
For patients, we would like to emphasize that antipyretics are in principle unnecessary for fever by infection and if you want to use any on of antipyretics, acetaminophen (paracetamol) is far safer than NSAIDs antipyretics.
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