Evaluation of cutaneous adverse drug reactions in a tertiary care hospital

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Author Details : Rhia Sebastian, Megaravalli R Manasa*, Thankappan TP

Volume : 5, Issue : 1, Year : 2019

Article Page : 20-23

https://doi.org/10.18231/2581-4729.2019.0005

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Abstract

Abstract

Introduction: Skin is one of the most frequently involved organ in adverse drug reactions. A wide spectrum of reactions ranging from maculopapular rashes to toxic epidermal necrolysis can be caused by different classes of drugs.

Objectives: To evaluate the cutaneous adverse drug reactions in a tertiary care hospital using standard assessment scales.

Materials and methods: A retrospective study was conducted in the Dermatology department of a tertiary care hospital between June 2013 – May 2017. All the inpatient and outpatient records were analysed for Cutaneous adverse drug reactions (CADRs) during the study period.

Results: Out of 124 patient case files reviewed, 90 patients were included in the study. Of these 90 patients, 55.6% were males. Maximum number of cases were in the age group of 20-39 years (37.8%). Fixed drug eruption and maculopapular rash were the most common CADRs reported. Type of drug reaction was not significantly associated with age and sex. The most common drugs implicated were antibiotics (33.3%) followed by NSAIDs (21.1%). Most of the patients were managed on outpatient basis (67.8%). Probable association was seen in 86.67% and 13.3% had a possible association. About 92.2% of CADRs were in the moderate category.

Conclusion: Commonly used drugs can cause CADRs. Hence careful use of drugs weighing the benefit risk ratio is essential. Pharmacovigilance will play a vital role in monitoring ADRs especially those due to the newer drugs.

Keywords: Cutaneous adverse drug reactions, Maculopapular rash, Antibiotics, NSAIDs.                   

Introduction

Discussion

In the present study a total of 90 patients were included. The youngest patient was of 8 years and the oldest 86 years. The maximum number of patients belonged to the age group of 20 to 39 years. Similar findings were noted in the studies by R Sharma et al^[5] and Pudukkadan et al.^[6] A systematic review of 3671 cases of CADRs by T K Patel et al showed maximum(54.42%) of patient distribution in 40 to 60 years of age group.^[7] Some studies have reported greater frequency in older age group.^[4] In our study 55.6% of patients were males. Similar observations were noted in a study by Sushma M et al.^[8] Some studies report higher incidence of drug reactions in females.⁴ Reaction rates increased with age and were higher in females (F:M-58: 1) in the data from the Italian spontaneous reporting system.^[9]

In this study maculopapular rash and fixed drug eruption were the most common types of reactions, both seen in 23 (25.6%) each. Most of the studies report maculopapular rash as the commonest type followed by fixed drug eruption (FDE).^[7] In Pudukkadan et al study FDE was the most common (31.1%) followed by maculopapular rash.^[6]This could be due to different patterns of drug usage.

SCAR reactions including Stevens Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity syndrome and acute generalised exanthematous pustulosis were noticed in 23.3% of patients. Of the 2595 reported adverse skin reactions in an Italian study, 17% were serious reactions.^[9] In another study on SCAR, of the 106 patients with CADR, 43 required hospitalisation and of this 25 were due to these severe type of reactions.^[10]

Another significant type of reaction was acneiform eruption noted in 8.9% of patients. R Sharma et al in their study reported acneiform eruptions in 11.3% of patients.^[5]

Among the drugs implicated the most common classes were antibiotics in 33.3% followed by NSAIDs in 21.1% and anticonvulsants in 14.4%. T K Patel et al in their review
of CADR in Indian population observed similar findings.^[7] In
a 9 year South Indian study of 404 patients, the drug classes implicated were antibiotics (45%) followed by antiepileptics (19%) and NSAIDs (19%).^[8] Sharma VK et al in their study found the causative as antimicrobials in 42.6%, anticonvulsants in 22.2% and NSAIDs in 18%.^[11] Other important classes of drugs were corticosteroids either topical or systemic and causing mainly acneiform eruptions. In our study, steroids were the causative drugs in 6.7% of patients. In the study done by R Sharma et al corticosteroids were found to be the third most common drug class implicated in CADR accounting for 14.6% of patients.^[5] S Ghosh et al in their study reported 4% of cutaneous drug reaction to be due to steroids.^[12] Drugs for hyperuricemia caused CADR in five patients of which allopurinol was the causative drug in three cases of TEN. In a study by T K Patel also it was reported as a common offending drug.^[7]

Among antibiotics penicillin group was the most common culprit in 40% followed by quinolones in 33.3%, cephalosporins in 10%, sulpha in 10% and 3.3% each for macrolide and tetracycline. In a study by S Thakkar et al CADRs due to fluoroquinolones were more frequent than cotrimoxazole and penicillins.^[13]In a Korean study of antibiotic related ADRs, quinolones (98 cases, 17%) and penicillins (88 cases, 15.3%) were the most common causative agents for skin and subcutaneous manifestations, followed by third generation cephalosporins in 86 cases (14.9%).^[14]

The ultimate goal of management is always to discontinue the offending medication if possible. The therapy for most drug eruptions is mainly supportive and treatment depends on the specific type of reaction.^[4] In our study most of the patients could be managed on outpatient basis 61 (67.8%) whereas 29 (32.2%) were treated as inpatients of which two were in the Intensive Care Unit. Of the 90 patients, 21 (23.3%) were treated with systemic steroids. In two patients with toxic epidermal necrolysis i.v. immunoglobulin was given.

According to the causality assessment using WHO-UMC categories, 78 (86.67%) had a probable association and 12 (13.3%) had a possible association. Causality assessment of ADRs is a method used for estimating the strength of relationship between drug(s) exposure and occurrence of adverse reaction(s).^[15] In a study by Amrinder R et al, the implicated drug was found to be a probable cause in 93.3% of patients, possible in 5% and certain in 1%.^[16] Severity assessment using Modified Hartwig and Siegel scale revealed that majority that is 83 (92.2%) were in the moderate category of which 58 (64.4%) were in level 3, 21 (23.3%) in level 4b and 4 patients in level 4a. 4 patients (4.4%) belonged to the severe category of which 2 (2.2%) were in level 5 and 2 (2.2%) in level 6. 3 (3.3%) patients were in the mild category. Out of total 120 cases of CADR maximum cases, 109 were of level 3 severity, 10 of level 4 and 1 of level 7 in the previous study.^[16] In our study also majority were in the level 3, moderate category. In a study most of cutaneous ADRs (82%) were moderately severe in nature, and 18% were mild in nature.^[17]

Conclusion

Physicians should take proper drug history, maintain records of a patient with CADR and warn the patient regarding the need to further avoid use of the same class of drug. Careful use of drugs weighing the benefit risk ratio is essential especially when used prophylactically. Pharmacovigilance system will be useful to monitor ADRs especially those due to the newer drugs.

Acknowledgements

We would like to thank the staff of Pharmacology and Dermatology departments of Pushpagiri Institute of Medical Sciences, Tiruvalla for their help and support.

Funding: None.

Conflict of Interest: None.

Ethical Approval: The Institutional Ethics committee has approved this study

References

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How to cite : Sebastian R, Manasa M R, Thankappan Tp, Evaluation of cutaneous adverse drug reactions in a tertiary care hospital. IP Indian J Clin Exp Dermatol 2019;5(1):20-23

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