Clinical pattern and causative agents of adverse cutaneous drug reactions in a tertiary care hospital SKIMS Soura Srinagar.

JMS SKIMS ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Surjeet Singh ◽  
Zahoor A Wafai ◽  
Ajaz Koul
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Pharmacovigilance Center ◽  
Causative Agents ◽  
Cutaneous Drug Reactions

Background: Adverse drug reactions are the most frequent side effects of drugs. Most of them being benign but can prove fatal sometimes. Aim: To study the different clinical spectrum of cutaneous adverse drug reactions and to determine causative drugs. Methods: It was a prospective hospital based study carried out for a period of 3 years. It was part of continuous adverse drug reaction monitoring carried out by our pharmacovigilance center at SKIMS. Results: Out of 1225 total adverse drug reactions 685 were enrolled as cutaneous ADR’s. Most common types observed were maculopapular rash (43.9%), fixed drug eruptions (36.2%) and urticaria (15.1%). The drugs most incriminated for various cutaneous ADR’s were antimicrobials (48.7%), anticonvulsants (22%), and NSAIDS (17.9%). Antimicrobials were also responsible for maximum of (58.3%) of severe cutaneous ADR’s like TEN and SJS. Conclusion: Pattern of cutaneous ADR’s and their causative drugs are similar to those observed in other regions with small variations, as reported by similar studies. However, due to emergence of newer drugs and differing trends in use of drugs, both pattern of cutaneous ADR’s as well as drugs causing them are changing every year. Further studies of similar nature with more expertise are required for safe use of drugs in future. JMS 2017;20(2):73-76  

scholarly journals Cutaneous adverse drug reactions in a tertiary care hospital: An observational study

2020 ◽  
Vol 1 (1) ◽  
pp. 6-9 ◽  
Author(s):  
Baijayanti Rath ◽  
Manas Ranjan Naik ◽  
Bhabagrahi Rath ◽  
Renuka Bhoi ◽  
Jai Prakash
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Developed Countries ◽  
Care Hospital ◽  
Severity Assessment ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Antitubercular Drugs ◽  
Drug Eruptions ◽  
Fixed Drug

Introduction: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. Aim and objective: This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. Methods: A total of 50 Patients with cutaneous adverse drug reactions who were included in our last study attended skin OPD, VIMSAR Burla, from June 2018 to September 2018 and were analyzed for causality assessment using the WHO-UMC scale and severity assessment using  Hartwig and Siegel's scale. Results: Out of 50 patients, 48 % belong to the age group 21-40 years. Around 44 % of CADRs were fixed drug eruptions. NSAID was found to be the most offending drug and it contributed to a maximum of 32 % of ADRs. 16 % of ADRs were found to be caused by antitubercular drugs. Paracetamol was the key NSAID, contributing 87.5 % of ADRs. Causality was certain, probable, and possible for 8 %, 24 %, and 60 % of ADRs respectively. Severity was mild for 64 % and moderate for 34 % of ADRs. Conclusions: NSAID and antitubercular drugs are the commonest drugs causing CADRs. Fixed drug eruption is the most common CADRs and the commonest drug was paracetamol. Causality grade was possible and the severity grade was mild.

scholarly journals Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

2018 ◽  
Vol 8 (1) ◽  
pp. 27
Author(s):  
Vijaya Chandra Reddy Konda ◽  
Sree Surya Durga Devi Pilla ◽  
A. Surekha ◽  
K. R. Subash ◽  
K. Umamaheswara Rao
Keyword(s):  
Adverse Drug Reactions ◽  
Continuous Monitoring ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
The Common ◽  
Clinical Patterns

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

A CLINICAL STUDY OF CUTANEOUS ADVERSE DRUG REACTIONS IN TERTIARY CARE HOSPITAL

2021 ◽  
pp. 24-26
Author(s):  
Jaydip Tank ◽  
Radha Dhudshia ◽  
Mitesh Thakkar ◽  
Bela Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Cutaneous Eruption ◽  
Johnson Syndrome ◽  
Culprit Drug ◽  
Fixed Drug ◽  
Steven Johnson Syndrome

The patterns of cutaneous eruption and the offending agent vary amongst the different population previously studied. This study aims to determine the different clinical patterns of cutaneous adverse drug reactions (CADRs) in our population and recognize the common drug implicated. A prospective observational study was conducted over a period of two years recording various CADRs. Out of the 630 patients, common reactions observed were Fixed drug eruption (25.71%), Urticaria / Angioedema (21.27%), Exanthematous rash(15.87%), Erythema multiforme(3.81%), Steven-Johnson Syndrome (4.13%) and Toxic epidermal necrolysis (2.07 %). The most common pharmacological group was Antimicrobials (37.01%), NSAIDS (16.64%), Anticonvulsants (7.61%) and Antiretroviral therapy (12.52%). Cotrimoxazole was the culprit in 11.11%, Nevirapine in 9.36%, Amoxycillin in 7.61% and Phenytoin in 5.23% of patients. 10 patients of TEN proved to be fatal. Among 15.56% HIV reactive patients, the most common pattern was exanthematous rash (45.91%) with Nevirapine(59.20%) as the most common culprit drug.

scholarly journals Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital

2017 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
B. Janardhan ◽  
D. Shailendra
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Clinical Manifestations ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Female Ratio ◽  
The Mean ◽  
Cutaneous Drug Reactions

<p class="abstract"><strong>Background:</strong> An adverse cutaneous drug reaction (ACDR) is defined as an undesirable clinical manifestation resulting from administration of a particular drug. With an ever increasing number of drugs and varied formulations being continuously made available it is important that a close watch on the risks of adverse drug reactions is looked for, to ensure safe use of medicines in the interest of the patient. In the present study our aim is to study the prevalence &amp; pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> All suspected cutaneous adverse drug reactions reported to the department of dermatology at MediCiti Institute of Medical Sciences during the two year period from January 2013 to December 2014 were included in this study. A thorough clinical examination of all these cases &amp; details related to the drug use and clinical manifestations of the cutaneous adverse drug reaction were documented using a structured proforma. Naranjo scale was used to assess causality in all the causes of cutaneous adverse drug reactions.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients was 42 years (age range: 1-64 years). Most of them were in the age group of 30-39 years. The male to female ratio was 1.78:1. The most common type of skin eruptions observed were maculopapular rash (35.55%), urticaria (26.19%) and fixed drug eruption (17.87%). The mean duration between drug intake and appearance of rash was 4 days (range: 1-120 days)<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> The pattern of ACDRs and the drugs causing them in this study were similar to that reported in other studies both in terms of disease burden and clinical pattern. Knowledge of adverse cutaneous drug reactions will help to identify common medications contributing to dermatological reactions, so as to anticipate, prevent and limit their undue consequences<span lang="EN-IN">.</span></p>

scholarly journals Adverse cutaneous drug reactions reporting in a tertiary care teaching hospital in Eastern India: a retrospective study

2020 ◽  
Vol 9 (9) ◽  
pp. 1381
Author(s):  
Manika Bose ◽  
Debasish Misra ◽  
Sansita Parida ◽  
Smita Das ◽  
Swati Mishra ◽  
...  
Keyword(s):  
Tertiary Care ◽  
Drug Reactions ◽  
Morphological Pattern ◽  
Common Drug ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Cutaneous Reactions ◽  
Cutaneous Drug Reactions ◽  
Major Drug ◽  
Cutaneous Drug Reaction

Background: Any unwanted changes to mucous membrane, skin, its appendages and drug eruptions related adverse events are known as adverse cutaneous drug reaction (ACDR). It has 2-5% incidence in developing countries. The current study was undertaken to analyse adverse cutaneous drug reactions spectrum clinically, drugs responsible, assessment of causality, severity, and preventability in our setup.Methods: Current study was an observational, retrospective, non-interventional analysis of voluntarily reported ADRs forms, between April 2018 and January 2020.  All cutaneous ADRs reported within this period were identified. Data obtained were expressed in numbers, percentages.Results: 130 cutaneous ADRs was reported during the period of study. Fixed drug eruptions (30%) was the most common cutaneous reaction. The most common causal drug groups were antimicrobials (58.5%). Amongst antimicrobials, ornidazole (8.5%) was the most common drug. The most common drug in NSAID group was paracetamol (14.6%). The major drug causing ACDRs in our study was Paracetamol (14.6%). Assessment of causality revealed 37.7% were probable and 62.3% were possible reactions. Assessment of severity showed 78.5% as mild and 21.5% as moderate. Assessment of preventability showed that 6.1% probably preventable and 93.9% not preventable.Conclusions: Knowledge of the pattern of cutaneous reactions and the causative drugs guides us in early diagnosis of the condition, better management and associated decrease in morbidity, mortality. In the current study, the most common causal drug group were antimicrobials. The most common morphological pattern and drug causing ACDRs were fixed drug eruptions and paracetamol, respectively.

scholarly journals A study of cutaneous adverse drug reactions in the outpatient department of Dermatology at a tertiary care center in Gujarat, India

2017 ◽  
Vol 6 (5) ◽  
pp. 1115
Author(s):  
Dinesh A. Chavda ◽  
Satish D. Suthar ◽  
Shradhanand Singh ◽  
Jayesh D. Balat ◽  
Sailesh P. Parmar ◽  
...  
Keyword(s):  
Hospital Admissions ◽  
Care Center ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Female Ratio ◽  
Drug Eruptions ◽  
Male Preponderance ◽  
Cutaneous Drug Reactions ◽  
A Prospective Study

Background: The data for adverse cutaneous drug reactions (ACDRs) is limited in Gujarat. The ACDRs are one of the frequent ADRs and cause of significant morbidity and mortality in patients of all areas of healthcare today. They are responsible for significant number of hospital admissions. Thus, the present study emphasises on the need and importance of an effective pharmacovigilance programme.Methods: A prospective study was undertaken in a 183 cases tertiary care teaching hospital of India. Male to female ratio, most common class of drug, individual drug causing ACDR, common types of ACDRs Parameters were studied. Other Parameters like Causality, preventability and severe or non-severe reactions were analyzed.Results: Majority of the patients (48%) with CADR belonged to the age group 25-44 followed by 45-64 (28%). Most frequent adverse cutaneous drug reactions reported were Urticaria (40%), Maculopapular rash (25%) & Fixed drug eruptions (21%) in decreasing order of frequency. Majority of reactions (96%) were Bizarre/Unpredictable in nature. As a group, antimicrobials (46%) were most frequently associated with CADR followed by NSAIDs (31%) and antiepileptics (11%).  Most of the reactions (93%) were mild-moderate and probable (77%) in nature. Approximately 60% of ACDRs reported in this study were preventable.Conclusions: There was slight male preponderance except acneiform eruptions. Cotrimoxazole being the most common offending drug then after Ibuprofen, Phenytoin among the anti-inflammatory, analgesics, antiepileptics class. Causality assessment resulted in high score 77% of probable category.

Cutaneous Drug Reactions in Children Attending a Tertiary Care Hospital

2020 ◽  
Vol 33 (2) ◽  
pp. 56-62
Author(s):  
Md Mostafizur Rahman ◽  
Md Azraf Hossain Khan ◽  
Pampa Chandra ◽  
Laila Shamima Sharmin ◽  
Fazlur Rahman ◽  
...  
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Stevens Johnson Syndrome ◽  
Care Hospital ◽  
Drug Reactions ◽  
Johnson Syndrome ◽  
Cutaneous Drug Reactions ◽  
Cutaneous Drug Reaction

Background: Cutaneous drug reaction (CDR) is a growing health hazard in the world. Adverse drug reactions are common complications in drug therapy. About 3-8% of all hospital admissions are the results of adverse drug reactions, among them 2-3% are children and these can cause significant disability to patients. Early identification and management of adverse cutaneous drug reaction has both short term and long term prognostic significance.  Objective: To know the cutaneous reaction to drugs in children in a tertiary care hospital.  Study design: Hospital based descriptive, observational study. Subjects: 50 children with cutaneous drug reactions were studied in the department of Dermatology and Pediatric respectively in Rajshahi Medical College Hospital, Rajshahi. Methods: Data were collected by detailed history taking, physical examination and laboratory investigations in a prefixed data collection sheet and with the help of GOLD guideline after taken informed consent of the patient. Results: This study showed a significant male predominance. Male: female ratio was 1.08:1 .In this study prevalence was highest among 1-5 years age group. Cotrimoxazole, NSAIDs, anticonvulsant and quinolone were most offending medications. Maculopapular eruption, Stevens Johnson Syndrome, fixed drug eruption and urticaria were most common morphological types. Majority of CDRs were noted with oral route of administration. It was observed that almost all the CDRs that were reported involved mainly the skin. Majority of adverse cutaneous drug reactions reported were moderate in severity. Conclusion: Frequency distribution of the offending drugs and the adverse reactions revealed that adverse cutaneous drug reactions occurred mostly by cotrimoxazole, NSAIDs and quinolones. Maculopapular rash and Stevens Johnson Syndrome were the most common morphological types. A better understanding of the mechanisms underlying CRDs is important in drug development and in patient care. TAJ 2020; 33(2): 56-62

scholarly journals Cutaneous drug reactions notified by ADR monitoring centre in a tertiary care hospital of Bihar

2016 ◽  
Vol 6 (1) ◽  
pp. 80
Author(s):  
Pramod Kumar Manjhi ◽  
Lalit Mohan ◽  
Harihar Dikshit ◽  
Hitesh Mishra ◽  
Manish Kumar ◽  
...  
Keyword(s):  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Care Hospital ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Monitoring Centre ◽  
Drug Classes ◽  
Clinical Patterns ◽  
Cutaneous Drug Reactions

Background: Cutaneous drug reactions are most frequent drug related adverse events which lead to early treatment discontinuations, high treatment cost and leading cause of morbidity and mortality. The aim of this study is to analyze the clinical patterns and offending drugs as well as their causality, severity and preventive strategies.Methods: All adverse drug reactions (ADRs) forms filled from May 2015 to April 2016 were scrutinized and forms with cutaneous drug reactions were analyzed and assessed for causality, severity and preventability.Results: Out of 300 ADR forms, 160 (53.34%) included cutaneous drug reactions. 68 (42.50%) patients were male and 92 (57.50%) were female. Maculopapular rash 58 (36.25%), fixed drug eruption (FDE) 31 (19.37), pruritus 27 (16.87%) and urticaria 19 (11.87%) were the common clinical patterns of cutaneous drug reactions. Most common offending drug classes included antibiotics, anti-inflammatory and steroidal agents. Causality assessment was done by using Naranjo’s algorithm. The result showed that out of 160 cutaneous drug reactions 141 (88.12%) ADRs were probable, 15 (9.37%) were classified as possible; 2 (1.25) doubtful and 2 (1.25%) were definitely related to the drug.Conclusions: The present study shows cutaneous drug reactions are commonly reported at ADR monitoring centre of this tertiary care hospital. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety.

scholarly journals Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital

2019 ◽  
Vol 6 (4) ◽  
pp. 1557
Author(s):  
Veereswara Rao Kurma ◽  
Triveni Manchu ◽  
Meena Kumari Amancharla ◽  
Kalyani Manchu ◽  
Pavan Kumar Kandula
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Paediatric Population ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Monitoring Centre

Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.

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