Transcript NIMESULIDE - Pediatric Oncall

NIMESULIDE
DR.B.B.SAHNI
SR.SPECIALIST
TATA CENTRAL HOSPITAL
DHANBAD
CONTROVERSY
• NIMESULIDE IS NOT A SAFE
DRUG FOR CHILDREN
• MEDIA REPORTS
• ACTION GROUPS
SYSTEMATIC REVIEW OF RANDOMIZED
CONTROLLED TRIALS IN 2003 BY
DR.H.PS.SACHDEV PAST PRESIDENT IAP
• Inclusion Criteria FOR 16 STUDIES FROM
GERMANY,INDIA,SWITZERLAND,ITALY,BEL
GIUM
• Studies with following pre-determined
criteria were included:
• (i) randomized trials with oral nimesulide
and a control group, receiving any other
analgesic, anti-inflammatory, antipyretic
agent or placebo; studies employing a
rectal route were not eligible;
• (ii) trials restricted to children £ 18 years
of age; and
• (iii) must have evaluated one or more
adverse effects as an outcome measure.
SYSTEMATIC REVIEW OF RANDOMIZED
CONTROLLED TRIALS IN 2003 BY
DR.H.PS.SACHDEV PAST PRESIDENT IAP
•
key message—
• For short-term use (£10 days) in
children, nimesulide is
as ‘unsafe’ or as ‘safe’ as other
analgesics-antipyretics.
Forest plot for relative risk of elevation of liver enzymes.
There is no significant
difference (P = 0.218) between nimesulide and the control
groups.
Forest plot for relative risk of epigastric pain, vomiting,
and diarrhea.
These symptoms were significantly (P = 0.008) lower in the
nimesulide group roughly half) in comparison to the control
groups. However, this difference was not significant (P =
0.276) if the control group of only paracetamol or placebo
(was considered (plot not shown).
Forest plot for relative risk of hypothermia. There is no
significant difference (P = 0.952) in
the risk of hypothermia between nimesulide and the control
groups
Forest plot for relative risk of gastrointestinal bleeding.
There is no significant
difference (P = 0.896) in the risk of gastrointestinal bleeding
between nimesulide
and the control groups.
IAP COMMITTEE FOR
PROTECTION OF CHILD
CONSUMER
• CHAIRPERSON-DR.S.C.ARYA PAST PRESIDENT-IAP
• The following sources and methods were utilized by
the Committee to formulate this Consensus
Statement: (i) Non-funded meta-analysis of 16
randomized controlled trials including 1254
children, which was conducted to specifically
resolve this controversy(1); (ii) Review of other
published literature on the subject; (iii) Opinions of
the speakers, faculty and delegates during a
specific session on this issue in the Indo-UK
Symposium on "Hot Topics in Pediatrics" on
February 1, 2003; (iv) Discussions with some of the
doctors who had expressed reservations about
usage of Nimesulide in the local press; (v)
Circulation of the draft recommendations to
members of the Committee unable to participate in
the Symposium
IAP COMMITTEE OF
PROTECTION FOR CHILD
CONSUMER REPORT
• For short-term (<10 days) use in children,
Nimesulide is as "safe" or "unsafe" as
other analgesic-antipyretics. There is no
significant increase(1) in the risk of
hypothermia, gastrointestinal bleeding,
epigastric pain, vomiting, diarrhea and
transient asymptomatic hepatic enzyme
elevation with Nimesulide as compared to
the control groups (Paracetamol, Placebo,
or other non-steroidal anti-inflammatory
drugs like Ibuprofen, Mefenamic Acid,
Salicylates).
IAPCPCC REPORTHEPATIC ADVERSE
REACTION
• The estimated incidence (all ages) of 1 per
1 million treated patients (lower than or
comparable to other non-steroidal antiinflammatory drugs) suggests that rare
cases of such liver injury may be caused
by a metabolic idiosyncrasy. Further, the
published "Case Reports" of serious
hepato-toxicity are mostly restricted to
prolonged usage (reported mean 2 months)
and adults (reported mean age 62 years)
Administration of Nimesulide, like other
NSAIDs should be avoided in known or
suspected liver disease or with the use of
other hepato-toxic drugs.
DELHI HIGH COURT
JUDGEMENT MARCH 2003
• JUDGEMENT BASED ON REPORTS OF
DRUG TECHNICAL ADVISORY BOARD
(DTAB)OF DRUG CONTROLLER OF INDIA
• IMA AND IAP REPORTS
• AIIMS REPORTS
• ADR CENTRES OF DELHI ,LUKNOW AND
BANGALORE
• STANDARD TEXT GUIDELINES OF DELHI
SOCIETY FOR PROMOTION OF RATIONAL
DRUGS
DELHI HIGHCOURT
OBSERVATIONS
• evidences available so far does not
indicate any causal relationship of
the drug with the alleged adverse
reactions
• 'Standard Treatment Guideline 2002'
(STG)of DELHI SOCIETY FOR
RATIONAL DRUGS recommended the
use of Nimesulide alongwith other
drugs like ibuprofen and
paracetamol for controlling fever in
adults as well as children.
RECOMMENDATIONS OF
DTAB
• The rationality of the formulations
containing Nimesulide with Paracetamol or
Muscle Relaxants was reviewed by the Sub
Committee in its meeting held on 30th
January, 2002, and the committee felt that
as such, fixed dose combinations of
NSAIDs like paracetamol, Diclofenec,
ibuprofen and with Nimesulide have been
in use for considerable period and well
accepted. There are no reports of any
adverse effects for these formulations
which are mostly used on short term basis
for relief from pain and
inflammation. These formulations may be
permitted to be continued. This opinion in
respect of Nimesulide has already been
provided to the Hon'ble Court.
IMA RECOMMENDATION
• Use of Nimesulide was suspended
only in 3 countries, though it is in
use in about 50 countries. Israel has
again permitted its use, after
evaluating its overall safety
data. According to him the survey
conducted by Indian Medical
Association was extensive one and
revealed that the drug is very useful
and well accepted by medical
community.
DEHI HIGH COURT
JUDGEMENT
• It may be stated at this juncture
that this Court took cognizance
of the matter because of the
alleged adverse effect of the
drug on children. That issue
has been cleared by the report
of the DTAB
DTAB REPORT
• After detailed deliberations,
members opined that having
considered the issues raised by
the petitioner and the overall data
on this drug, there is no ground
for banning of drug Nimesulide for
adult or pediatric use. The drug is
considered to be as safe or unsafe
as any other commonly used
NSAID.
DTAB REPORT (CONTD.)
• The drug has dose
convenience, as it is to be
taken only twice a day and
have lesser Gastro-intestinal
irritation.