Analgesics for pediatric use

S Malhotra1, P Pandhi

  • 1Department of Clinical Pharmacology, PGIMER, Chandigarh.

Indian Journal of Pediatrics
|September 14, 2000
PubMed

Insights

Nimesulide use is rising, with serious liver damage concerns, especially in children. Post-marketing surveillance is crucial to prevent adverse drug reactions in developing countries.

Area of Science:

  • Pharmacology
  • Hepatology
  • Pediatrics

Background:

  • Nimesulide usage is increasing globally.
  • Concerns regarding nimesulide-induced hepatotoxicity, particularly in pediatric populations, have emerged.
  • Two fatalities linked to fulminant hepatic failure have been reported.

Observation:

  • Nimesulide is approved in India, with multiple pediatric formulations available.
  • Post-marketing surveillance systems for adverse drug reactions in India are lacking effective mechanisms for detection and reporting.

Findings:

  • The increasing prevalence of nimesulide and inadequate surveillance pose risks.
  • Potential for undetected adverse drug reactions, including severe hepatotoxicity, is high.

Implications:

  • Rapid approval of drugs like nimesulide, especially when alternatives exist, may be inadvisable in India and other developing nations.
  • Strengthening post-marketing surveillance is essential to ensure pediatric drug safety.
  • Risk-benefit assessments for nimesulide in pediatric populations require careful consideration.

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