Risk of serious skin and subcutaneous tissue disorders for nimesulide among the pediatric population: a jeopardy identified through the analysis of global individual case safety reports

ABSTRACT

Background

The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs).

Research Design and Methods

The global individual case safety reports on nimesulide-induced SSTDs available at VigiBase® were analyzed up to 31 March 2023. Disproportionality analyses viz. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were performed to identify the quantitative signals.

Results

Out of 33,983,649 de-duplicated cases available in the VigiBase_®, 1,664,134 (4.9%) were in pediatrics below 12 years of age. Among these, cases attributed to nimesulide were 251, of which 126 (50.2%) were on SSTDs. Among all the SSTDs reported for nimesulide, the serious reactions like urticaria [PRR = 2.3; lower bound (LB) ROR = 1.7; IC₀₂₅ = 0.6], Stevens-Johnson syndrome (SJS) [PRR = 28.3; LB ROR = 18.2; IC₀₂₅ = 3.2], angioedema [PRR = 7.5; LB ROR = 4.5; IC₀₂₅ = 1.7], and toxic epidermal necrolysis (TEN) [PRR = 27.4; LB ROR = 11.5; IC₀₂₅ = 1.5] were identified as potential signals. In comparison with non-SSTDs, SSTDs reported for nimesulide were significantly higher among children (2–11 years, 90.5%), from India (38.9%), and by the physician (60.3%).

Conclusions

Identifying the giant quantitate association between nimesulide and serious & life-threatening reactions like SJS and TEN, precautionary measures need to be taken by the regulatory authorities to prevent nimesulide-induced SSTDs among the pediatric population.

KEYWORDS:

• Nimesulide
• pediatric population
• skin and subcutaneous tissue disorders
• Stevens-Johnson syndrome
• toxic epidermal necrolysis

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Author contributions

All authors contributed as follows to qualify for the requirements for authorship:

Conception and design: K Undela; acquisition of data: K Undela, V Kalaiselvan, SK Gudi and SK Viswam; analysis and interpretation of data: K Undela, V Kalaiselvan and SK Ali; drafting the paper: SK Gudi, SK Viswam and SK Ali; revising it critically for important intellectual content: K Undela and V Kalaiselvan.

Acknowledgments

The authors thank the providers of the VigiBase®, FDA Adverse Event Reporting System (FAERS), and OpenVigil 2.1. Thanks to the authorities of the National Institute of Pharmaceutical Education and Research (NIPER) Guwahati and the Indian Pharmacopoeia Commisssion (IPC), National Coordination Centre-Pharmacovigilance Programme of India (PvPI) for their constant support while conducting this study.

Additional information

Funding

This paper was not funded.