Cutaneous adverse drug reactions in Indian population : A systematic review
BACKGROUND: Epidemiological data is limited for cutaneous adverse drug reactions (CADRs) in India. Most of the Indian studies have small sample size and are of limited duration.
AIMS: The aim of this study is to analyze CADRs with reference to the causative drugs and their clinical characteristics in Indian population.
MATERIALS AND METHODS: As per selection criteria, electronic databases were searched for publications describing CADRs from January-1995 to April-2013 by two independent investigators. Data of the causative drugs and clinical characteristics were extracted and summarized by absolute numbers, percentages, ranges, and means as presented by the authors. The subgroup analysis of causative drugs was performed for causality assessment, severe or nonsevere reactions and occurrence of common CADRs. Studies showing "definite" and "probable" categories of causality analysis were labeled as "definite and probable causality (DPC) studies". The other included studies were labeled as "non-DPC studies".
RESULTS: Of 8337 retrieved references, 18 prospective studies were selected for analysis. The pooled incidence was 9.22/1000 total among outpatient and inpatient cases. Commonly observed reactions were maculopapular rash (32.39%), fixed drug eruptions (FDEs) (20.13%), urticaria (17.49%) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (6.84%). The major causative drug groups were antimicrobials (45.46%), nonsteroidal anti-inflammatory drugs (NSAIDs) (20.87%) and anti-epileptic drugs (14.57%). Commonly implicated drugs were sulfa (13.32%), β-lactams (8.96%) and carbamazepine (6.65%). High frequency of CADRs is observed with anti-epileptic drugs in DPC studies only. Carbamazepine, phenytoin and fluoroquinolones had higher severe to nonsevere cutaneous reaction ratio than other drugs. Antimicrobials were the main causative drugs for maculopapular rash, FDEs and SJS/TEN, and NSAIDs for the urticaria. The mortality for overall CADRs, SJS/TEN, and exfoliative dermatitis were 1.71%, 16.39%, and 3.57%, respectively. "Definitely preventable", "probably preventable" and "not preventable" categories CADRs were 15.64%, 63.14%, and 34.64%, respectively.
CONCLUSION: Antimicrobials, NSAIDs and antiepileptic are common causative agents of CADRs in India. Antiepileptic agents show high rates of severe cutaneous reactions.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:5 |
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| Enthalten in: |
Indian dermatology online journal - 5(2014), Suppl 2 vom: 01. Dez., Seite S76-86 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Patel, Tejas K [VerfasserIn] |
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| Links: |
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| Themen: |
Anti-epileptic drugs |
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| Anmerkungen: |
Date Completed 16.01.2015 Date Revised 10.04.2022 published: Print Citation Status PubMed-not-MEDLINE |
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| doi: |
10.4103/2229-5178.146165 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM245389997 |
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| 245 | 1 | 0 | |a Cutaneous adverse drug reactions in Indian population |b A systematic review |
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| 500 | |a Date Revised 10.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a BACKGROUND: Epidemiological data is limited for cutaneous adverse drug reactions (CADRs) in India. Most of the Indian studies have small sample size and are of limited duration | ||
| 520 | |a AIMS: The aim of this study is to analyze CADRs with reference to the causative drugs and their clinical characteristics in Indian population | ||
| 520 | |a MATERIALS AND METHODS: As per selection criteria, electronic databases were searched for publications describing CADRs from January-1995 to April-2013 by two independent investigators. Data of the causative drugs and clinical characteristics were extracted and summarized by absolute numbers, percentages, ranges, and means as presented by the authors. The subgroup analysis of causative drugs was performed for causality assessment, severe or nonsevere reactions and occurrence of common CADRs. Studies showing "definite" and "probable" categories of causality analysis were labeled as "definite and probable causality (DPC) studies". The other included studies were labeled as "non-DPC studies" | ||
| 520 | |a RESULTS: Of 8337 retrieved references, 18 prospective studies were selected for analysis. The pooled incidence was 9.22/1000 total among outpatient and inpatient cases. Commonly observed reactions were maculopapular rash (32.39%), fixed drug eruptions (FDEs) (20.13%), urticaria (17.49%) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (6.84%). The major causative drug groups were antimicrobials (45.46%), nonsteroidal anti-inflammatory drugs (NSAIDs) (20.87%) and anti-epileptic drugs (14.57%). Commonly implicated drugs were sulfa (13.32%), β-lactams (8.96%) and carbamazepine (6.65%). High frequency of CADRs is observed with anti-epileptic drugs in DPC studies only. Carbamazepine, phenytoin and fluoroquinolones had higher severe to nonsevere cutaneous reaction ratio than other drugs. Antimicrobials were the main causative drugs for maculopapular rash, FDEs and SJS/TEN, and NSAIDs for the urticaria. The mortality for overall CADRs, SJS/TEN, and exfoliative dermatitis were 1.71%, 16.39%, and 3.57%, respectively. "Definitely preventable", "probably preventable" and "not preventable" categories CADRs were 15.64%, 63.14%, and 34.64%, respectively | ||
| 520 | |a CONCLUSION: Antimicrobials, NSAIDs and antiepileptic are common causative agents of CADRs in India. Antiepileptic agents show high rates of severe cutaneous reactions | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anti-epileptic drugs | |
| 650 | 4 | |a antimicrobials | |
| 650 | 4 | |a causative drugs | |
| 650 | 4 | |a cutaneous adverse drug reaction | |
| 650 | 4 | |a nonsteroidal anti-inflammatory drugs | |
| 650 | 4 | |a severe cutaneous reactions | |
| 700 | 1 | |a Thakkar, Sejal H |e verfasserin |4 aut | |
| 700 | 1 | |a Sharma, Dc |e verfasserin |4 aut | |
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