Although selective Cyclo-oxygenase-2 (COX-2)
inhibitors are associated with a reduced risk of GI
adverse events compared with other conventional
NSAIDs, the continuing use of Nimesulide for Indian
children is really shocking. Numerous studies across
the globe where Nimesulide preparations are (were)
available have established the life-threatening
hepatotoxic effects of Nimesulide not only in children
but also in adults(1-4). Nimesulide is not used in the
USA and as mentioned in the report, several European
countries have also banned the use of Nimesulide in
view of its unacceptable rate of serious adverse
reactions. Israel also withdrew the use of Nimesulide
in 1999 after reports of several cases of severe hepatic
failure(3).
Even though some studies have indicated that
Nimesulide may be a good choice for long-term
treatment of osteoarthritis (OA), especially for patients
with associated gastric problems(5), there can be no
dispute that other NSAIDs like Acetaminophen or
Ibuprofen are far better choice as anti-pyretic or
analgesic, especially for children(6). There can be no
rationale for selecting Nimesulide as the first drug of
choice for fever or pain in children. Unfortunately,
published studies from India(7,8) and the huge
revenues that Nimesulide sale generates in India
(according to the report) clearly suggest rampant use of
this drug across the country. It is astonishing to note
from one study that there are 12 pediatric preparations
of Nimesulide available in India(7). Such reports only
affirm the pervasive use of the drug in the pediatric
patient population in India.
Another unfortunate aspect of drug abuse in India is
that there is hardly any dependable post-marketing
surveillance about adverse drug reaction (ADR).
Further, unlike in the West, Indian physicians are not
really under the scanner of any controlling agency and
thus, hardly care to keep up with the changing medical
literature or current information about ADR as
published reports from India indicate7. Although
incidence of Nimesulide-induced liver injury has been
estimated only about 0.1 per 100,000 patients in the
West, such numbers are based on spontaneous
reporting data and sale units and are prone to the bias
in the system(9). Severe cases of ADR from
Nimesulide are likely to be much higher in India where
such drugs are freely available even without
prescription. More important, there can be no argument
that patients receiving Nimesulide should be closely
monitored for evolving hepatic failure by serial liver
function tests. Many Indian physicians are not likely to
follow these necessary guidelines for using
Nimesulide for simple economic reasons. Even if the
Indian drug control agencies are reluctant to take
imminent steps to ban the use of Nimesulide
completely, they should immediately forbid its use for
treatment of fever or pain in children. There is plethora
of scientific data to suggest that Nimesulide should not
be used as the primary mode of therapy as anti-pyretic
or analgesic, especially for children where much better
and safer choices are available. Many developed
countries have already banned the use of Nimesulide.
It will be truly unfortunate if the Indian government and
the Medical Council of India (MCI) wait for another
"committee" report before stopping the use of
Nimesulide even for the treatment of pain or fever and
let other innocent children die needlessly.
1. Sbeit B, Krivoy N, Shiller M, Farah R, Cohen HI,
Struminger L, Reshef R. Nimesulide-induced acute
hepatitis. Ann. Pharmacother. 2001; 35:1049-1052.
2. Ferreio S, Vivas F, Jorquera AB, Dom’uez J, Herrera
A, Fern’ez MJ, Olcoz JL, Urbina JOD.
Nimesulide-induced hepatotoxicity. Case report and
bibliography review. Gastroenterol Hepatol. 2000; 23:
428-430.
3. Schattner A, Sololovskaya N, Cohen J. Fatal hepatitis
and renal failure during treatment with nimesulide. J.
Internal Med. 2000; 247: 153-155.
4. Merlani G, Fox M, Oehen HP, Cathomas G, Renner
EL, Fattinger K, Schneemann M, Kullak-Ublick GA.
Fatal hepatoxicity secondary to nimesulide. Eur. J. Clin.
Pharmacol. 2001; 57: 321-326.
5. Huskisson EC. Nimesulide, a balanced drug for the
treatment of osteoarthritis. Clin. Exp. Rheumatol.
2001; 19: S21-25.
6. Litalien C, Jacqz-Aigrain E. Risks and benefits of
nonsteroidal anti-inflammatory drugs in children: a
comparison with paracetamol. Paediatr. Drugs 2001;
3: 817-858.
7. Malhotra S, Pandhi P. Analgesics for pediatric use.
Indian J. Pediatr. 2000; 67: 589-590.
8. Chandra J, Bhatnagar SK. Antipyretics in children.
Indian J. Pediatr. 2002; 69: 69-74.
9. Boelsterli UA. Mechanisms of NSAID-induced
hepatotoxicity: focus on minesulide. Drug Saf. 2002;
25: 633-648.
Rapid Response:
Abuse of Nimesulide in India
Although selective Cyclo-oxygenase-2 (COX-2)
inhibitors are associated with a reduced risk of GI
adverse events compared with other conventional
NSAIDs, the continuing use of Nimesulide for Indian
children is really shocking. Numerous studies across
the globe where Nimesulide preparations are (were)
available have established the life-threatening
hepatotoxic effects of Nimesulide not only in children
but also in adults(1-4). Nimesulide is not used in the
USA and as mentioned in the report, several European
countries have also banned the use of Nimesulide in
view of its unacceptable rate of serious adverse
reactions. Israel also withdrew the use of Nimesulide
in 1999 after reports of several cases of severe hepatic
failure(3).
Even though some studies have indicated that
Nimesulide may be a good choice for long-term
treatment of osteoarthritis (OA), especially for patients
with associated gastric problems(5), there can be no
dispute that other NSAIDs like Acetaminophen or
Ibuprofen are far better choice as anti-pyretic or
analgesic, especially for children(6). There can be no
rationale for selecting Nimesulide as the first drug of
choice for fever or pain in children. Unfortunately,
published studies from India(7,8) and the huge
revenues that Nimesulide sale generates in India
(according to the report) clearly suggest rampant use of
this drug across the country. It is astonishing to note
from one study that there are 12 pediatric preparations
of Nimesulide available in India(7). Such reports only
affirm the pervasive use of the drug in the pediatric
patient population in India.
Another unfortunate aspect of drug abuse in India is
that there is hardly any dependable post-marketing
surveillance about adverse drug reaction (ADR).
Further, unlike in the West, Indian physicians are not
really under the scanner of any controlling agency and
thus, hardly care to keep up with the changing medical
literature or current information about ADR as
published reports from India indicate7. Although
incidence of Nimesulide-induced liver injury has been
estimated only about 0.1 per 100,000 patients in the
West, such numbers are based on spontaneous
reporting data and sale units and are prone to the bias
in the system(9). Severe cases of ADR from
Nimesulide are likely to be much higher in India where
such drugs are freely available even without
prescription. More important, there can be no argument
that patients receiving Nimesulide should be closely
monitored for evolving hepatic failure by serial liver
function tests. Many Indian physicians are not likely to
follow these necessary guidelines for using
Nimesulide for simple economic reasons. Even if the
Indian drug control agencies are reluctant to take
imminent steps to ban the use of Nimesulide
completely, they should immediately forbid its use for
treatment of fever or pain in children. There is plethora
of scientific data to suggest that Nimesulide should not
be used as the primary mode of therapy as anti-pyretic
or analgesic, especially for children where much better
and safer choices are available. Many developed
countries have already banned the use of Nimesulide.
It will be truly unfortunate if the Indian government and
the Medical Council of India (MCI) wait for another
"committee" report before stopping the use of
Nimesulide even for the treatment of pain or fever and
let other innocent children die needlessly.
1. Sbeit B, Krivoy N, Shiller M, Farah R, Cohen HI,
Struminger L, Reshef R. Nimesulide-induced acute
hepatitis. Ann. Pharmacother. 2001; 35:1049-1052.
2. Ferreio S, Vivas F, Jorquera AB, Dom’uez J, Herrera
A, Fern’ez MJ, Olcoz JL, Urbina JOD.
Nimesulide-induced hepatotoxicity. Case report and
bibliography review. Gastroenterol Hepatol. 2000; 23:
428-430.
3. Schattner A, Sololovskaya N, Cohen J. Fatal hepatitis
and renal failure during treatment with nimesulide. J.
Internal Med. 2000; 247: 153-155.
4. Merlani G, Fox M, Oehen HP, Cathomas G, Renner
EL, Fattinger K, Schneemann M, Kullak-Ublick GA.
Fatal hepatoxicity secondary to nimesulide. Eur. J. Clin.
Pharmacol. 2001; 57: 321-326.
5. Huskisson EC. Nimesulide, a balanced drug for the
treatment of osteoarthritis. Clin. Exp. Rheumatol.
2001; 19: S21-25.
6. Litalien C, Jacqz-Aigrain E. Risks and benefits of
nonsteroidal anti-inflammatory drugs in children: a
comparison with paracetamol. Paediatr. Drugs 2001;
3: 817-858.
7. Malhotra S, Pandhi P. Analgesics for pediatric use.
Indian J. Pediatr. 2000; 67: 589-590.
8. Chandra J, Bhatnagar SK. Antipyretics in children.
Indian J. Pediatr. 2002; 69: 69-74.
9. Boelsterli UA. Mechanisms of NSAID-induced
hepatotoxicity: focus on minesulide. Drug Saf. 2002;
25: 633-648.
Competing interests:
None declared
Competing interests: No competing interests