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

References

• Modi A, Desai M, Shah S, et al. Analysis of cutaneous adverse drug reactions reported at the regional ADR monitoring center. Indian J Dermatol. 2019;64(3):250. doi: 10.4103/ijd.IJD_682_16
   PubMed Web of Science ®Google Scholar
• Bigby M. Rates of cutaneous reactions to drugs. Arch Dermatol. 2001;137(12):765–770. doi: 10.1001/archderm.137.12.1639
   PubMedGoogle Scholar
• Svensson CK, Cowen EW, Gaspari AA. Cutaneous drug reactions. Pharmacol Rev. 2001;53(3):357–379.
   PubMed Web of Science ®Google Scholar
• Gohel D, Bhatt S, Malhotra S. Evaluation of dermatological adverse drug reaction in the outpatient department of dermatology at a tertiary care hospital. Indian J Pharm Pract. 2014;7(3):42–49. doi: 10.5530/ijopp.7.3.9
   Google Scholar
• Bansod K, Bashir MM, Ingle S. Adverse drug reaction profile in Amravati region of India: a pharmacovigilance study. J Pharm Bioallied Sci. 2020;12(2):155. doi: 10.4103/jpbs.JPBS_226_19
   PubMed Web of Science ®Google Scholar
• Krishna J, Babu GC, Goel S, et al. A prospective study of incidence and assessment of adverse cutaneous drug reactions as a part of Pharmacovigilance from a rural northern Indian medical school. Int Arch Integr Med. 2015;2:108–115.
   Google Scholar
• Sharma S, Jayakumar D, Palappalli D. Pharmacovigilance of cutaneous adverse drug reactions among patients attending dermatology department at a tertiary care hospital. Indian Dermatol Online J. 2019;10(5):547. doi: 10.4103/idoj.IDOJ_419_18
   PubMedGoogle Scholar
• Mockenhaupt M. Epidemiology of cutaneous adverse drug reactions. Allergol Select. 2017;1(1):96–108. doi: 10.5414/ALX01508E
   PubMedGoogle Scholar
• Chan HL, Stern RS, Arndt KA, et al. The incidence of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. A population-based study with particular reference to reactions caused by drugs among outpatients. Arch Dermatol. 1990;126(1):43–47. doi: 10.1001/archderm.1990.01670250049006
   PubMedGoogle Scholar
• Strom BL, Carson JL, Halpern AC, et al. A population-based study of Stevens-Johnson syndrome. Incidence and antecedent drug exposures. Arch Dermatol. 1991;127(6):831–838. doi: 10.1001/archderm.1991.01680050075007
   PubMedGoogle Scholar
• Roujeau JC, Stern RS. Severe adverse cutaneous reactions to drugs. N Engl J Med. 1994;331(19):1272–1285. doi: 10.1056/NEJM199411103311906
   PubMed Web of Science ®Google Scholar
• Patel T, Barvaliya M, Sharma D, et al. A systematic review of the drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Indian population. Indian J Dermatol Venereol Leprol. 2013;79(3):389. doi: 10.4103/0378-6323.110749
   PubMed Web of Science ®Google Scholar
• Marques LP, Villarinho ALCF, Melo MDG, et al. Fixed drug eruption to nimesulide: an exuberant presentation confirmed by patch testing. An Bras Dermatol. 2018;93(3):470–472. doi: 10.1590/abd1806-4841.20187338
   PubMed Web of Science ®Google Scholar
• Kumaran S, Sandhu K, Saikia UN, et al. Nimesulide induced bullous fixed drug eruption of the labial mucosa. Indian J Dermatol Venereol Leprol. 2004;70(1):44–45.
   PubMedGoogle Scholar
• Sarkar R, Kaur C, Kanwar AJ. Extensive fixed drug eruption to nimesulide with cross‐sensitivity to sulfonamides in a child. Pediatr Dermatol. 2002;19(6):553–554. doi: 10.1046/j.1525-1470.2002.00232.x
   PubMed Web of Science ®Google Scholar
• Bennett A, Villa G. Nimesulide: an NSAID that preferentially inhibits COX-2, and has various unique pharmacological activities. Expert Opin Pharmacother. 2000;1(2):277–286. doi: 10.1517/14656566.1.2.277
   PubMedGoogle Scholar
• Central Drugs Standard Control Organisation (CDSCO). List of drugs prohibited for manufacture and sale through gazette notifications under section 26A of drugs & cosmetics act 1940 by the ministry of health and family welfare. [cited 2023 Aug 18]. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Consumer_Section_PDFs/banneddrugs.pdf
   Google Scholar
• Saha K. Use of nimesulide in Indian children must be stopped. BMJ. 2003;326(7391):713. doi: 10.1136/bmj.326.7391.713
   PubMedGoogle Scholar
• Indian pharmacopoeia commission. Nimesulide: prohibited for use in children below 12 years of age. [cited 2023 Aug 18]. https://www.ipc.gov.in/images/Nimsulide_Poster_-_Final.jpg
   Google Scholar
• Palapra H, Viswam SK, Kalaiselvan V, et al. SGLT2 inhibitors associated pancreatitis: signal identification through disproportionality analysis of spontaneous reports and review of case reports. Int J Clin Pharm. 2022;44(6):1425–1433. doi: 10.1007/s11096-022-01476-7
   PubMed Web of Science ®Google Scholar
• OpenVigil. Open tools for data-mining and analysis of pharmacovigilance data. [cited 2023 May 1]. https://openvigil.sourceforge.net/
   Google Scholar
• Chatterjee S, Pal J, Biswas N. Nimesulide-induced hepatitis and toxic epidermal necrolysis. J Postgrad Med. 2008;54(2):150. doi: 10.4103/0022-3859.40786
   PubMed Web of Science ®Google Scholar
• Karunaratne D, Khatri R. Nimesulide induced Stevens- Johnson syndrome. Nepal J Dermatol Venereol Leprol. 1970;9(1):25–27. doi: 10.3126/njdvl.v9i1.5765
   Google Scholar
• Tursen U, Kaya TI, Kokturk A, et al. Lichenoid photodermatitis associated with nimesulide. Int J Dermatol. 2001;40(12):767–768. doi: 10.1046/j.1365-4362.2001.01332-2.x
   PubMed Web of Science ®Google Scholar
• Khan S. Nimesulide and adverse drug reactions: Time for a database. J Postgrad Med. 2008;54(3):242. doi: 10.4103/0022-3859.41819
   PubMed Web of Science ®Google Scholar
• Polimeni G, Salvo F, Cutroneo P, et al. Adverse reactions induced by NSAIDs and antibacterials. Drug Saf. 2006;29(5):449–459. doi: 10.2165/00002018-200629050-00006
   PubMed Web of Science ®Google Scholar
• Rainsford K. Relationship of nimesulide safety to its pharmacokinetics: assessment of adverse reactions. Rheumatology. 1999;38(90001):4–10. doi: 10.1093/rheumatology/38.suppl_1.4
   PubMedGoogle Scholar
• Litalien C, Jacqz-Aigrain E. Risks and benefits of nonsteroidal anti-inflammatory drugs in children. Paediatr Drugs. 2001;3(11):817–858. doi: 10.2165/00128072-200103110-00004
   PubMedGoogle Scholar
• Gupta P, Sachdev HPS. Safety of oral use of nimesulide in children: systematic review of randomized controlled trials. Indian Pediatr. 2003;40(6):518–531.
   PubMedGoogle Scholar
• Rainsford KD. Nimesulide - actions and uses. 1st ed. Switzerland: Birkhäuser Basel; 2005. doi: 10.1007/3-7643-7410-1
   Google Scholar
• Conforti A, Leone R, Moretti U, et al. Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide. Drug Saf. 2001;24(14):1081–1090. doi: 10.2165/00002018-200124140-00006
   PubMed Web of Science ®Google Scholar