DRUG-INDUCED CUTANEOUS REACTIONS: A PHARMACOVIGILANCE STUDY
DOI:
https://doi.org/10.22159/ijpps.2024v16i3.48975Keywords:
Adverse drug reactions, Pharmacovigilance, Antiepileptic drugsAbstract
Objective: Drug-induced cutaneous reactions are common problem in our country and can range from simple rash to severe reactions. Early recognition of these reactions enables early identification and withdrawal of offending drugs, thereby reducing morbidity and mortality. So present study aimed to assess clinical pattern of drug-induced cutaneous reactions in Dermatology OPD.
Methods: This study was an open, non-comparative, non-interventional, observational study conducted on patients visiting dermatology department to see the clinical pattern of drug-induced cutaneous reactions. A total of 60 patients with suspected cutaneous adverse drug reactions were recruited. A detailed physical examination was done by a physician, including drug intake during 3 w preceding reactions and type of drug reactions.
Results: Most frequently reported cutaneous drug reactions were Stevens-Johnson Syndrome (23%), Maculopapular rash (18%) Toxic Epidermal Necrolysis (15%) and were caused by antiepileptic drugs in 21(35%) patients, followed by antibiotics in 17(28.33%) cases, NSAID’s in 7(11.6%) cases, antitubercular drugs in 3(5%) and antiretroviral drugs in 3(5%) cases. A high proportioned of these reactions (50%) were moderate (31%) of these were severe because they require hospitalisation or increased the duration of stay in hospital or were life-threatening in (1%). Principal offending drug was phenytoin.
Conclusion: A good knowledge of ADRs, a careful history taking and watchful approach while prescribing of drugs can prevent many of adverse drug reactions. These facts justify the development of an intensive programme of pharmacovigilance.
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References
Narwat A, Sharma V. Prescription pattern of antiepileptic drugs in indoor patients at tertiary care hospital in Haryana, India. Int J Basic Clin Pharmacol. 2018;7(3):537-40. doi: 10.18203/2319-2003.ijbcp20180670.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9, PMID 11072960.
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA. 1979;242(7):623-32. doi: 10.1001/jama.1979.03300070019017, PMID 449002.
Hausmann O, Schnyder B, Pichler WJ. Etiology and pathogenesis of adverse drug reactions. Chem Immunol Allergy. 2012;97:32-46. doi: 10.1159/000335614, PMID 22613852.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45. doi: 10.1038/clpt.1981.154, PMID 7249508.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32. doi: 10.1093/ajhp/49.9.2229, PMID 1524068.
Sado DM. Oxford textbook of clinical pharmacology and drug therapy. J R Soc Med. 2002 Sep;95(9):472. doi: 10.1177/014107680209500918.
Royer RJ. Mechanism of action of adverse drug reactions: an overview. Pharmacoepidemiol Drug Saf. 1997;6(3)Suppl 3:S43-50. doi: 10.1002/(sici)1099-1557(199710)6:3+3.3.co;2-u, PMID 15073754.
Desai C. Meyler's side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. Indian J Pharmacol. 2016;48(2):224.
Valeyrie Allanore L, Sassolas B, Roujeau JC. Drug-induced skin, nail and hair disorders. Drug Saf. 2007;30(11):1011-30. doi: 10.2165/00002018-200730110-00003, PMID 17973540.
Ajayi FO, Sun H, Perry J. Adverse drug reactions: a review of relevant factors. J Clin Pharmacol. 2000;40(10):1093-101. doi: 10.1177/009127000004001003, PMID 11028248.
Roujeau JC, Stern RS. Severe adverse cutaneous reactions to drugs. N Engl J Med. 1994;331(19):1272-85. doi: 10.1056/NEJM199411103311906, PMID 7794310.
Naldi L, Conforti A, Venegoni M, Troncon MG, Caputi A, Ghiotto E. Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions. Br J Clin Pharmacol. 1999;48(6):839-46. doi: 10.1046/j.1365-2125.1999.00096.x, PMID 10594488.
Demoly P, Gomes ER. Drug hypersensitivities: definition, epidemiology and risk factors. Eur Ann Allergy Clin Immunol. 2005;37(6):202-06. PMID 16156397.
Fiszenson Albala F, Auzerie V, Mahe E, Farinotti R, Durand Stocco C, Crickx B. A 6-month prospective survey of cutaneous drug reactions in a hospital setting. Br J Dermatol. 2003;149(5):1018-22. doi: 10.1111/j.1365-2133.2003.05584.x, PMID 14632808.
Sharma R, Dogra D, Dogra N. A study of cutaneous adverse drug reactions at a tertiary center in Jammu, India. Indian Dermatol Online J. 2015;6(3):168-71. doi: 10.4103/2229-5178.156384, PMID 26009710.
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