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Guidelines for Elective Pediatric Fiberoptic Intubation
Published on: January 17, 2011
Analgesics for pediatric use
1Department of Clinical Pharmacology, PGIMER, Chandigarh.
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.
Abstract:
The use of nimesulide is increasing and recently, concerns have been raised regarding its hepatotoxicity, especially in children. At least two deaths due to fulminant hepatic failure have been attributed to nimesulide. In India, nimesulide has been approved and about twelve pediatric preparations are available. Lack of effective postmarketing surveillance means that adverse drug reactions may not be picked or reported. Therefore, quick approval of those drugs for which substitutes are available may not be desirable in India and in other developing countries.
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