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

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.

2021 ◽  
pp. 24-26
Author(s):  
Jaydip Tank ◽  
Radha Dhudshia ◽  
Mitesh Thakkar ◽  
Bela Shah

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.


JMS SKIMS ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Surjeet Singh ◽  
Zahoor A Wafai ◽  
Ajaz Koul

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  


2021 ◽  
Vol 14 (02) ◽  
pp. 701-708
Author(s):  
Kiran M ◽  
Nagabushan H

Background: Tuberculosis is one of the major public health concerns in India. Treatment of tuberculosis need multidrug combinations, which is associated with increased incidence of adverse drug reactions (ADRs). Hence there is a need of active monitoring for adverse effects in patients who are on antitubercular treatment (ATT). Objectives: To study the pattern of ADRs caused by antitubercular drugs and to assess causality, severity and predisposing factors. Methodology: A prospective observational study was conducted for 6 months in tertiary care hospital of Mandya. A total of 74 patients of tuberculosis who experienced ADRs were included in the study after obtaining informed consent. Their demographic, treatment and ADR data were collected and analysed. Causality was assessed using WHO scale and Naranjo’s algorithm, whereas severity was assessed by Modified Hartwig and Siegel scale. Results: Among 74 patients, 55(74.32%) were males and 19 (25.67%) were females. A total of 86 ADRs were recorded amongst 74 patients, as 11 patients experienced two ADRs. During intensive and continuation phase of treatment, 65 (87.63%) and 9 (12.16%)patients experienced ADRs respectively. Gastrointestinal side effects and hepatotoxicity were the most frequently observed ADRs with 23 (26.7%) each, followed by pruritus and rashes in 18 (20.93%) patients.63.51% of ADRs had an association with fixed dose combination (FDC) of isoniazid, rifampicin, pyrazinamide and ethambutol. As per WHO scale and Naranjo’s algorithm majority of ADRs were probable with 44 (59.45%) and 58 (78.37%) respectively. Most of the ADRs belonged to mild (67.56%) category as per Modified Hartwig and Siegel scale. Conclusion: ADRs induced by ATT are common. Hence counselling of patients regarding their life style along with early detection and management will minimize the occurrence of ADRs and improvethe adherence to treatment.


Author(s):  
Vijaya Chandra Reddy Konda ◽  
Sree Surya Durga Devi Pilla ◽  
A. Surekha ◽  
K. R. Subash ◽  
K. Umamaheswara Rao

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.


Author(s):  
Seema Rani ◽  
Bhawna Sharma ◽  
Tarun . ◽  
Sanjeev Kumar ◽  
Rahul Saini

Background: Antibiotics are considered to be commonly used drugs in hospital setting due to higher prevalence of infectious diseases especially in India. So, the present study was conducted to assess the incidence of adverse drug reactions (ADRs) due to antibiotics and analyze for causality of adverse drug events reported.Methods: The present retrospective and observational, study was conducted in BPS GMC for women, Khanpur Kalan, Sonepat, Haryana which is a 500 bedded government medical hospital situated in rural area between March 2016 to February 2019 (i.e., 3 years). Patients of either sex or age who developed ADRs by any route were included in the study.Results: 300 (38.65%) cases were reported due to antibiotics out of total 776 ADR cases. 3% cases were serious. Adults (65%) were found to be most commonly affected by ADRs. Among antibiotics, cephalosporins and penicillins (15.98%) were the major culprit to cause adverse events followed by nitroimidazoles (15.2%) and antitubercular drugs and fluoro quinolones (13.16%). The most affected organ system was skin (49.33%) followed by the gastrointestinal system (33%). As per WHO scale of causality assessment, 33.33% and 67.67% reported cases were found to probably and possibly related to adverse events respectively.Conclusions: Antibiotics are most commonly prescribed drugs so its monitoring regarding ADRs may benefit the clinicians in early identification and management of ADRs so that quality of life of patient can be safeguarded at an earliest.


Author(s):  
Sowmya Kaimal ◽  
Jithendriya Madhukara

Aim: To collect data pertaining to oral drug provocation testing (DPT) in hospitalized patients with antiretroviral (ARV)/antitubercular agent–induced rashes. Methods: Patients with cutaneous adverse drug reactions (ADRs) to ARV/antitubercular drugs and who underwent oral DPT during a 5-year period were included in this study. Results: Data were collected from the records of 21 patients. Of the 21, 19 had HIV infection. The most commonly implicated drug was nevirapine (NVP), followed by cotrimoxazole and antitubercular agents. Of the 11 ADRs that occurred on rechallenge, the ADR on rechallenge was similar in clinical presentation to the initial ADR in 6 patients, while a different rash was elicited in 5 patients. Conclusion: Oral DPT is a safe and effective tool to accurately diagnose ADRs, especially in patients on multiple drugs and in situations such as HIV infection and tuberculosis where second-line agents are expensive and/or not easily available through the national AIDS control/tuberculosis programs.


2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization


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