1. As we had to
condense our report into a letter, we omitted many details Dr. Lewin
has referred to(1).
2. Our study was not
mandatory but voluntary, undertaken to investigate whether sporadic
reports of liver toxicity in western literature(2,3) which point to
female sex and old age as risk factors, was prima facie a concern for
Indian children who may receive nimesulide suspension.
3. Our was a
naturalistic study of routine pediatric practice. Hence, there were no
inclusion and exclusion criteria, nor any control group.
4. All participating
pediatricians were provided a copy of the prescribing information,
which mentions that nimesulide should not be used in "moderate to
severe hepatic impairment". Yet, two patients with
"hepatitis" received nimesulide. Only a naturalistic survey
can reveal such instances. As for the two children who developed
yellowish discoloration, we recorded what was reported, as is the case
with all adverse event reporting systems.
5. We wanted
practitioners to report serious liver toxicity, if any, and
investigate it as they thought proper. We had committed to reimburse
expenses for laboratory investigations, wherever incurred.
6. The average age of
the subjects was 48.3 months (SD 10.53); the dose varied from 2.5 ml
(25 mg) 12 hourly to 5 ml (50 mg) 8 hourly; the duration of treatment
ranged from 3 to more than 14 days.
7. We invited 600
pediatricians to participate, of whom 430 responded. The remaining did
not drop out; they did not reply. Thus they were not excluded. Since
the decision to participate was voluntary, there was no conflict of
interest.
8. All data received
were analyzed. As a descriptive study, it has provided useful
information on the product’s safety.
9. As for drop outs, 74
children (2%) did not return for the end-of-treatment visit: of these,
56 were found to have improved, 3 had not responded, and 15 were not
traceable.
10. Though the
reference quoted by us are not indexed in the NML database MEDLINE, it
is a peer reviewed journal cited in other databases such as ISI,
SciSearch and Embase among others(4). Similar findings and views have
been reported in another review from a journal indexed in the MEDLINE
database as well(5).
11. Conscious
observation for adverse events by the prescribing physicians was
planned to ensure that all events encountered by them were captured.
The judgment of casual relationship of an adverse event to the drug
was left to the pediatrician.
