DOI: 10.18410/jebmh/2015/646
ORIGINAL ARTICLE
A PROSPECTIVE STUDY OF CUTANEOUS ADVERSE DRUG REACTION
IN COASTAL DISTRICT OF ANDHRA PRADESH
J. Vijayashree1, Anand Acharya2
HOW TO CITE THIS ARTICLE:
J. Vijayashree, Anand Acharya. “A Prospective Study of Cutaneous Adverse Drug Reaction in Coastal District
of Andhra Pradesh”. Journal of Evidence based Medicine and Healthcare; Volume 2, Issue 31, August 03,
2015; Page: 4597-4600, DOI: 10.18410/jebmh/2015/646
ABSTRACT: An adverse drug reaction can be defined as “an appreciably harmful or unpleasant
reaction, resulting from an intervention related to the use of a medicinal product, which predicts
hazard from future administration and warrants prevention or specific treatment, or alteration of
the dosage regimen, or withdrawal of the product”. This is a prospective study conducted at two
tertiary centers in coastal Andhra Pradesh during April 2013 to June 2015. Out of 164 cases of
coetaneous ADR, 63% were male and 36.58%were female, Maculo popular rashes were most
common cutaneous drug reaction. Out of all drugs antimicrobial agent were the most common
drugs which is responsible for cutaneous ADR.
KEYWORDS: Cutaneous drug reaction, Coastal Andhra Pradesh.
INTRODUCTION: An adverse drug reaction can be defined as “an appreciably harmful or
unpleasant reaction, resulting from an intervention related to the use of a medicinal product,
which predicts hazard from future administration and warrants prevention or specific treatment,
or alteration of the dosage regimen, or withdrawal of the product.(1)
The frequency and clinical patterns of cutaneous reactions are influenced by drug use,
prevalence of specific conditions (e.g. HIV Infection) and pharmacogenetic traits of a population
and that may vary greatly among the different population around the world.(2) Spectrum of
cutaneous reaction may vary from simple urticaria to Steven Johnson syndrome, Toxic epidermal
hydrolysis and DRESS. Monitoring and reporting ADR is the important part of pharmacovigilance
program of India (PPI) present study is designed. To examine various type of cutaneous drug
reaction and its causative agent in coastal district of Andhra Pradesh.
MATERIAL AND METHODS: This is a prospective study conducted at two tertiary centers in
coastal Andhra Pradesh during April 2013 to June 2015. All the suspected adverse drug reaction
of all age groups and boat the sex where included in the study.
Information regarding adverse drug reaction was collected on suspected ADR reporting
form of PVPI. Written informed consent was taken from each individual before enrollment in to
the study. Diagnosis was made by proper history taking and medication document.
Exclusion documents criteria:
1. In appropriate mediation history.
2. Clinical diagnosis is not matching the drug reaction.
Duration of rash, morphology associated mucosal, systemic involvement of lesion
improvement on withdrawal of drugs, recurrence when drug was again started.
J of Evidence Based Med & Hlthcare, pISSN- 2349-2562, eISSN- 2349-2570/ Vol. 2/Issue 31/Aug. 03, 2015 Page 4597
DOI: 10.18410/jebmh/2015/646
ORIGINAL ARTICLE
RESULT: During two year of study around 164 patients were enrolled for study, out of that 104
male and 60 female, between the age group 1yr. to 70yr., out of 164 pt. most of the pt. were in
the age between 20 to 50yr.
Among all pharmacotherapecetic agent anti-microbial agents were most common drug
which is responsible for cutaneous reaction, that is 39.02%, among then sulfonamide (21.8%)
was most common followed by fluroquionolones (18.75%) penicillin, (18.75) and macrolides
(15.62%).
NSAIDS accounted for 39.0%.
Anti-epileptic drugs accounted for 9.75%.
Maculo popular rashes are most common type of reaction which was 36.50%, cutaneous
drug reaction that is 21.95%, fixed drug emption angioedema and erythema multiforme were
6.09% and 1.2% respectively. Stephen Johnson syndrome and TEN was rare that is 2.43% and
1.2% respectively.
Male
Female
Total
104 (63.42) 60 (36.58) 164
Table 1
Age
No
1 - 15 Yrs. 20
15 - 30 Yrs. 25
30 - 45 Yrs. 55
45 - 60 Yrs. 39
60 - 75 Yrs. 15
Table 2
Pharmacotherapaeutic agent
Anti-microbial agents
%
12.19
15.24
39.63
23.78
9.14
No.
-64
No.
Sulfonamides
14
Fluroquinolones
12
penicillin’s
12
macrolides
10
cephalosporin’s
4
Anti-tubercular drugs
6
Other drugs
6
NSAIDS
51
Anti-epileptics
16
Anti-cancer drugs
5
Anti-malarial
4
β - blockers
2
Diuretics
2
ACE inhibitors
1
TOTAL
164
Table 3: Causative Agents and their
%
21.8
18.75
18.75
15.62
6.25
9.37
9.37
%
39.02
31.09
9.75
3.04
2.43
1.21
1.21
0.6
100%
Percentage
J of Evidence Based Med & Hlthcare, pISSN- 2349-2562, eISSN- 2349-2570/ Vol. 2/Issue 31/Aug. 03, 2015 Page 4598
DOI: 10.18410/jebmh/2015/646
ORIGINAL ARTICLE
Maculopopular rashes
60
36.58%
Urticaria
36
21.95%
Fixed drug eruptions
34
20.73%
Erythema multiforme
10
6.09%
Angioedema
2
1.20%
Stephen Johnsonsyndrome
4
2.43%
Toxic epidermal necrolysis (TEN)
2
1.20%
Others
16
9.75%
TOTAL
164 100%
Table 4: Types of rashes and their Percentage
DISCUSSION: Out of 164 cases of coetaneous ADR, 63% were male and 36.58%were female,
which is similar to the study of Sharma et al.(3) but B nit similar to the study of Faize.(4) out of all
drugs antimicrobial agent were the most common drugs which is responsible for cutaneous ADR,
as reported earlier by Sarita.(5) Maculo popular rashes were most common cutaneous drug
reaction, which similar to the study.(6) Among the anti-microbial agent sulphonamide was the
most common drug which caused with ADR and next drug was NSAID, similar to other study.(7,8)
CONCLUSION: Cutaneous drug reaction can occur with many drugs and its severity varies from
urticaria to SJS, TEN and DRESS. It is believed that medication error is 50 – 100 times common
then ADES. So for prevention of ADR, best practices to be followed are to reduce the error.
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Venereol. 2014 Apr; 149 (2):207-18.
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tertiary center in Jammu, India Year: 2015 | Volume: 6 | Issue: 3 | Page: 168-171.
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J of Evidence Based Med & Hlthcare, pISSN- 2349-2562, eISSN- 2349-2570/ Vol. 2/Issue 31/Aug. 03, 2015 Page 4599
DOI: 10.18410/jebmh/2015/646
ORIGINAL ARTICLE
7. Amparo Hernandez-Salazar, Samuel Ponce de Leon-Rosales, Sigfrido Rangel-Frausto,
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AUTHORS:
1. J. Vijayashree
2. Anand Acharya
PARTICULARS OF CONTRIBUTORS:
1. Associate Professor, Department of DVL,
Great Eastern Medical School and
Hospital, Srikakulam.
2. Professor, Department of Pharmacology,
KIMS, Amalapuram.
NAME ADDRESS EMAIL ID OF THE
CORRESPONDING AUTHOR:
Dr. Anand Acharya,
Professor,
Department of Pharmacology,
KIMS, Amalapuram.
E-mail: anand_kims@yahoo.co.in
Date
Date
Date
Date
of
of
of
of
Submission: 27/07/2015.
Peer Review: 28/07/2015.
Acceptance: 30/07/2015.
Publishing: 31/07/2015.
J of Evidence Based Med & Hlthcare, pISSN- 2349-2562, eISSN- 2349-2570/ Vol. 2/Issue 31/Aug. 03, 2015 Page 4600