Recently media (Television and Newspapers) have suggested that
Nimesulide, a commonly used antipyretic and analgesic, may not be a safe
drug, especially for children. The Committee for Protection of Child
Consumer (CPCC) was therefore requested by the Executive Board of IAP to
deliberate on the issue and to make specific recommendations regarding
the safety of using this drug in children. 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 (all members listed in
Appendix I). The statement was not intended to and nor does it
attempt to guide preferential use of one analgesic-antipyretic over
another. To retain scientific indepen-dence, no funding was taken from
any source for formulating this statement.
Consensus Statement
• 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).
• Nimesulide ingestion, similar to other
non-steroidal anti-inflammatory drugs (NSAIDs), has been associated
with rare and unpredictable but serious hepatic adverse reactions. The
estimated incidence (all ages) of 1 per 1 million treated patients
(lower than or comparable to other non-steroidal anti-inflammatory
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.
• There is limited data for drawing concrete
inferences below the age of six months (as for other NSAIDs).
• To prevent over dosage, particularly in view of
the higher concentration, taste and relatively longer half-life of the
drug, clinicians should prescribe the exact syrup dosage in
milliliters and carefully explain the frequency of administration.
• The drug manufacturers should dilute the
concentration of the syrup to reduce the possibility of over dosage. A
warning about its risk of over dosage should be mentioned clearly.
(Practice of medicine is dynamic. Any set of
recommendations can be modified with further scientific evidence. Please
do let us know of any adverse effects of any drug or vaccine you come
across - Dr. S.C. Arya, Chairman, IAP Committee for Protection of Child
Consumer, B-453, New Friends Colony, New Delhi 110 065, India. E-mail:
[email protected])
The Committee Members: S.C. Arya (Chairperson); B.K. Dutt; Piyush
Gupta; Satish Pandya; Baldev Prajapati (Convener); Anupam Sachdev; H.P.S.
Sachdev (President IAP, Ex-officio); Nitin Shah (Secretary IAP,
Ex-officio)
