A prospective study of cutaneous adverse drug reaction in coastal district of
Andhra Pradesh.
Dr.J.Vijayashree, Dr.Anand Acharya
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 between 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.
Key word:-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 urticeria 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
ogent in coastal district of Andhra pradesh.
Material and method:-This is a prospective study conducted at two tertiary centers in coastal
Andhra Pradesh between 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 mater the reaction.
Duration of rash, morphology associated mucosal, systemic involvement of lesion improvement on
withdrawal of drugs, recurrence when drug was again started.
Result: - During two year of study around 164 patient were enrolled for study, out of that 104
male and 60 female, between the age group 1 yr to 70 yr, out of 164 pt. most of the pt were in the
age between 20 to 50yr.
Among all pharmacotherapecetic agent anti-microbial agent 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 multiformi were 6.09% and
1.2% respectively .Stephen Johnson syndrome and TEN was rare that is 2.43% and 1.2% respectively.
Table:-1
Male
Female
Total
104 (63.42)
60 (36.58)
164
Table :-2
Age
No
%
1 - 15 Yrs
20
12.19
15 - 30 Yrs
25
15.24
30 - 45 Yrs
55
39.63
45 - 60 Yrs
39
23.78
60 - 75 Yrs
15
9.14
TABLE:-4Causative Agents and their Percentage
Pharmacotherapaeutic agent
NO
%
-64
39.02
Anti microbial agents
NO
%
Sulfonamides
14
21.8
Fluroquinolones
12
18.75
pencillins
12
18.75
macrolides
10
15.62
cephalosporins
4
6.25
Anti tubercular drugs
6
9.37
Other drugs
6
9.37
NSAIDS
51
31.09
Anti epileptics
16
9.75
Anti cancer drugs
5
3.04
Anti malarials
4
2.43
β - blockers
2
1.21
Diuretics
2
1.21
ACE inhibitors
1
0.6
TOTAL
164
100%
TABLE-5Types of rashes and their Percentage
Maculo papular rashes
Urticaria
Fixed drug eruptions
Erythema multiformi
Angioedema
Stephen Johnson syndrome
Toxic epidermal necrolysis (TEN )
Others
60
36.58%
36
21.95%
34
20.73%
10
6.09%
2
1.20%
4
2.43%
2
1.20%
16
9.75%
164
100%
TOTAL
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
urticeria to SJS,TEN and DRESS. It is believed that medication error are 50 – 100 times common then
ADES.So for prevention of ADR best practices to be follows to reduce the error.
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