[e-drug] RFI: Nimesulide ADRs? (3)

["Chandra Gulhati" <seeemgee@yahoo.co.uk>]

E-DRUG: RFI: Nimesulide ADRs? (3)
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India does not have the required infrastructure to
effectively monitor adverse drug reactions (ADRs).
Therefore doctors and regulators have to depend upon
information from other countries and institutions such
as USFDA, MHRA, TGA etc. for approving or banning any
drug such as astemizole, terfenadine, phenformin,
rofecoxib etc.

Unfortunately Nimesulide is not approved for use in
major western countries such as USA, Britain, Canada,
Australia, Denmark etc. Therefore its ADRs can not be
monitored.

Following certain nimesulide-related deaths in
Portugal and Finland, the European Medicine Evaluation
Agency (EMEA)reviewed the safety aspects of Nimesulide
and banned its use in children below 12 years.

In adults, its use was restricted to just three
disorders: acute pain, osteoarthritis and
dysmenorrhoea. Its earlier use for fever is not
permitted in EU.

In India, the Drugs Controller General (DCGI)has not
taken any action following EMEA directive. Its use is
permitted right from Day 0 (i.e. neonate) up to adults
for a wide variety of disorders including fever.

Dr. Chandra M. Gulhati
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
e-mail: indianmims@yahoo.co.in
seeemgee@yahoo.co.uk