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We organized a survey to investigate the recent concern that nimesulide
may cause hepatic injury in children(1,2) even though, unlike other
NSAIDs, nimesulide has rarely been implicated in this adverse
reaction(1). We requested 600 pediatricians in the country to record and
report the tolerability of Nise®
suspension (nimesulide 50 mg/5 ml) in up to 10 consecutive patients
treated by them with this product according to the approved prescribing
information. We received 4097 case report forms from 430 pediatricians.
Eighty-one patients received paracetamol in addition to nimesulide. The
nature and incidence of reported adverse events (AE) are shown in Table
I. This AE profile of nimesulide in children is similar to that
reported earlier(3) across all age groups. Four events, hypothermia-2,
hemetemesis-1, muscle pains-1, required hospitalization of patients, but
all subsided after stopping nimesulide. Two patients having hepatitis
received nimesulide but did not experience any AE. Yellowish
discoloration of skin was noticed in two children, but subsided on
stopping the drug and was considered unrelated to nimesulide by the
pediatricians. This study was designed to assess the use of nimesulide
suspension under real-practice conditions as opposed to clinical trial
conditions. While absence of close monitoring of each patient is its
limitation, the size of the cohort studied and the conscious recording
of AEs make some amends for it. Therefore, the absence of any nimesulide-related
hepatoxi-city in this study should help allay any undue concern about
the safety of this drug in children.
Table I__Adverse events and their incidence
|
System Adverse event
|
No. of patients
|
(%)*+
|
|
Gastrointestinal
|
129
|
(3.1)+
|
|
Vomiting
|
55
|
(1.34)
|
|
Burning stomach/
|
25
|
(0.60)
|
|
irritation in stomach
|
|
Pain abdomen
|
20
|
(0.50)
|
|
Diarrhea
|
17
|
(0.40)
|
|
Nausea
|
7
|
(0.17)
|
|
Black stool
|
4
|
(0.10)
|
|
Hematemesis
|
1
|
(0.02)
|
|
Skin and mucous membrane
|
72
|
(1.7)+
|
|
Itching/rash/urticaria
|
62
|
(1.50)
|
|
Cold, clammy skin
|
4
|
(0.10)
|
|
Stomatitis
|
2
|
(0.04)
|
|
Yellow discoloration
|
2
|
(0.04)
|
|
Dry, red lips
|
1
|
(0.02)
|
|
Bleeding gums
|
1
|
(0.02)
|
|
Renal
|
13
|
(0.3)+
|
|
Generalized edema
|
4
|
(0.10)
|
|
Hematuria
|
4
|
(0.10)
|
|
Reduced urine output
|
2
|
(0.04)
|
|
Burning micturition
|
2
|
(0.04)
|
|
Nephritis
|
1
|
(0.02)
|
|
CNS
|
16
|
(0.4)+
|
|
Drowsiness
|
5
|
(0.12)
|
|
Dizziness
|
4
|
(0.10)
|
|
Irritability
|
6
|
(0.15)
|
|
Heavy headedness
|
1
|
(0.02)
|
|
Other
|
56
|
(1.3)+
|
|
Puffiness of face/eyelids
|
29
|
(0.70)
|
|
Hypothermia
|
13
|
(0.31)
|
|
Excessive sweating
|
7
|
(0.17)
|
|
Muscle pain
|
3
|
(0.07)
|
|
Chest pain
|
1
|
(0.02)
|
|
Joint swelling
|
1
|
(0.02)
|
|
Peripheral cyanosis
|
1
|
(0.02)
|
|
Worsening
|
1
|
(0.02)
|
* Base = 4097
Total patients reporting any adverse event = 261 (6%).
+ Some patients had >1 AE.
Contributors:
Concept and design of study: MVS, KS, JB. SK; data management: MVS, KS;
data analysis and interpretation: MVS, KS; drafting and revision of
article: MVS, KS, JB, SK. The guarantor for the manuscript will be KS.
Funding:
Dr. Reddy’s Laboratories, Hyderabad.
Competing interests:
The authors are employees of
Dr. Reddy’s Laboratories, a manufacturer of nime-sulide.
M.V. Srishyla,
K. Sireesha,
J. Bhaduri,
S. Kumaresan,
Corporate Medical Services,
Dr. Reddy’s Laboratories,
7-1-27, Ameerpet, Hyderabad 500 016, India.
Correspondence to:
Ms. K. Sireesha.
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