A clinicoepidemiological study of fixed drug eruptions at a tertiary centre of North India

Background: Various studies have found the overall incidence of cutaneous adverse drug reactions (CADR’s) in developed countries as 1-3%, while the incidence in developing countries is thought to be higher between 2 and 5%. FDEs’ share is seen to be about 15 -30% of all CADR’s as reported in various studies. Aim of the research work was to study the clinical and epidemiological features of fixed drug eruptions and to identify probable culprit drug or drugs using Naranjo ADR probability scale and to provide information to the patient regarding the drug responsible for his/her drug rash.Methods: A total of 180 patients of fixed drug eruptions were taken up for study who presented to skin OPD at a tertiary centre of North India. Diagnosis was made on the basis of history of drug intake prior to drug eruption, repetition of similar lesions on same as well as new sites on intake of same drug with improvement of skin lesions on discontinuation of the causative drug. Further on examination, skin lesions with typical morphology compatible with FDE were seen. Causality of the FDE was assessed according to the NARANJO ADR probability scale.Results: A total of 180 patients of FDE were studied. Males outnumbered the females. The most common class of drug implicated was antimicrobials seen in 115 patients followed by NSAIDS 65 patients. Regarding the clinical presentation both skin and mucosal involvement was seen. The most common skin lesions were erythematous to hyperpigmented and violaceous macules followed by bullous FDE.Conclusions: In summary, early recognition of FDE is important not only for the dermatologists but also for the clinicians of other specialties, so that the culprit drug is recognized and stopped immediately. Drug reactions are a common reason for litigation and has medicolegal pitfalls.

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

Journal of Pharmacovigilance and Drug Research ◽

10.53411/jpadr.2020.1.1.2 ◽

2020 ◽

Vol 1 (1) ◽

pp. 6-9 ◽

Cited By ~ 1

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.

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A Review of Adverse Cutaneous Drug Reactions Resulting from the Use of Interferon and Ribavirin

Canadian Journal of Gastroenterology ◽

10.1155/2009/651952 ◽

2009 ◽

Vol 23 (10) ◽

pp. 677-683 ◽

Cited By ~ 42

Author(s):

Nisha Mistry ◽

Jonathan Shapero ◽

Richard I Crawford

Keyword(s):

Side Effects ◽

Drug Reactions ◽

Drug Induced ◽

Common Cause ◽

Injection Site Reactions ◽

Drug Eruptions ◽

Fixed Drug ◽

Life Threatening ◽

Cutaneous Drug Reactions ◽

Systemic Drug

Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions.

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Cutaneous reactions to drugs

Oxford Textbook of Medicine ◽

10.1093/med/9780198746690.003.0565 ◽

2020 ◽

pp. 5752-5760

Author(s):

Sarah Walsh ◽

Daniel Creamer ◽

Haur Yueh Lee

Keyword(s):

Adverse Drug Reactions ◽

Adverse Reactions ◽

Normal Function ◽

Stevens Johnson Syndrome ◽

Drug Reactions ◽

Drug Induced ◽

Drug Eruptions ◽

Fixed Drug ◽

Iatrogenic Illness ◽

Systemic Symptoms

Adverse reactions to medications are common and important cause of iatrogenic illness. Severe cutaneous adverse drug reactions include toxic epidermal necrolysis, Stevens–Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, which together constitute 2% of all adverse drug reactions and may be life-threatening. Less severe drug-induced skin reactions such as exanthems, urticaria, lichenoid drug rashes, and fixed drug eruptions are more common, sometimes termed benign cutaneous adverse reactions, and generally resolve without sequelae. Drugs may also cause adverse events due to alteration of the normal function of the skin or its appendages. This may take the form of photosensitivity, abnormal pigmentation, or disrupted growth of hair or nails.

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Epidemiological profile of occupational ocular injury in a tertiary eye care centre of North India

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20202506 ◽

2020 ◽

Vol 7 (6) ◽

pp. 2164

Author(s):

Monika Dahiya ◽

Mohit Dua

Keyword(s):

Manufacturing Industry ◽

Vision Loss ◽

Research Work ◽

Developed Countries ◽

Safety Training ◽

North India ◽

Ocular Injury ◽

Economic Productivity ◽

Ocular Injuries ◽

Epidemiological Profile

Background: Occupational ocular injuries are quite common among industrial and agricultural workers. It is an important cause of preventable vision loss in developing as well as developed countries. The principal objective of our research work was to study epidemiological profile of occupational ocular injuries and use of protective eye wear at workplace in North India.Methods: A prospective, hospital based observational study was conducted on 400 patients of occupational ocular injuries attending emergency services and OPD in Regional Institute of Ophthalmology, PGIMS Rohtak, Haryana, India during June 2016 to March 2020.Results: Out of 400 patients of occupational ocular injuries, majority were male (92%) and most common age group affected was 31-40 years (48%) followed by 21-30 years (30%). Most common injured patients were of manufacturing industry (45%) followed by construction site (30%) and agriculture based industry (25%). Metallic foreign body (70%) was found to be the most common cause of occupational ocular injury in 70% cases followed by chemical injury in 10% cases. Ocular injuries were more common in temporary workers (65%) who were not having proper safety training and not using protective devices at workplace.Conclusions: Occupational ocular injuries most commonly affect young productive population leading to temporary or permanent vision loss. Avoidance of protective glasses and lack of basic safety training make them more vulnerable for ocular injuries. Therefore, all workers should be encouraged to adopt basic safety measures and proper safety training should be given to them. It will not only help in reducing the ocular morbidity, but will also enhance the economic productivity.

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Paracetamol induced bullous fixed drug eruptions

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20195559 ◽

2019 ◽

Vol 7 (12) ◽

pp. 4800

Author(s):

Kalyani Pai Kakode ◽

Varun Pai Kakode

Keyword(s):

Reaction Monitoring ◽

Drug Reactions ◽

Over The Counter ◽

Adverse Drug Reaction Monitoring ◽

Delay In Diagnosis ◽

Prompt Treatment ◽

Good Safety Profile ◽

Drug Eruptions ◽

Fixed Drug ◽

Inflammatory Action

Paracetamol is a commonly used antipyretic and analgesic with a weak anti-inflammatory action with a good safety profile in children and adults. This has resulted in its over prescription and large over the counter sale. Thus, adverse drug reactions due to paracetamol may be easily overlooked resulting in delay in diagnosis. Author present a case report of a 12 year old boy with bullous fixed drug eruptions due to paracetamol while he tolerated NSAIDS well. This highlights the need of adverse drug reaction monitoring and reporting, for early detection and prompt treatment of drug related morbidity and the cautious use of even the most commonly used drugs.

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

10.36106/ijsr/5100984 ◽

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.

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20203623 ◽

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.

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A study of pattern of nonvenereal genital dermatoses of male attending skin OPD of tertiary centre in Kalaburagi

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20173922 ◽

2017 ◽

Vol 3 (3) ◽

pp. 407

Author(s):

Ashok S. Hogade ◽

Shantanu Mishra

Keyword(s):

External Genitalia ◽

Diagnostic Dilemma ◽

Sexually Transmitted ◽

Tertiary Centre ◽

Lichen Simplex Chronicus ◽

Drug Eruptions ◽

Fixed Drug ◽

Steatocystoma Multiplex ◽

Male Patients ◽

Male External Genitalia

Background: Dermatoses involving genital areas are not always sexually transmitted. The diseases, which are not sexually transmitted, are referred as nonvenereal dermatoses. These disorders are the cause of considerable concern to patients causing mental distress and guilt feeling in them. Nonvenereal dermatoses are quiet often a diagnostic dilemma to the treating physician also. The aim was to determine clinical and epidemiological pattern of nonvenereal dermatoses of male external genitalia.Methods: This was a descriptive study of 50 consecutive male patients over age of 18 years, with genital lesions of nonvenereal origin, attending the skin outpatient department of BTGH, Kalaburagi. Study was done for a period of 6 months.Results: The study included 50 male patients with nonvenereal genital lesions. A total of 14 nonvenereal genital dermatoses were noted. The most common nonvenereal genital dermatoses were vitiligo (20%), fixed drug eruptions (16%), scabies (14%), pearly penile papule (10%), and dermatophytoses (10%). Other dermatoses included psoriasis, plasma cell balanitis or Zoon's balanitis, lichen simplex chronicus, lymphangioma circumscriptum, squamous cell carcinoma, scrotal dermatitis, lichen planus, steatocystoma multiplex and candidiasis.Conclusions:This study helps in understanding the etiological causes of nonvenereal genital dermatoses and their pattern in this region.

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20185085 ◽

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.

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A study of clinical spectrum of patterns of cutaneous adverse drug reactions in a tertiary care hospital

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20195670 ◽

2019 ◽

Vol 6 (1) ◽

pp. 14

Author(s):

Narendra Gangaiah ◽

Veena Thimmappa ◽

Harish Kumar Gajam ◽

Naveen Kumar

Keyword(s):

Drug Reaction ◽

Adverse Drug Reactions ◽

Past History ◽

Clinical Spectrum ◽

Care Hospital ◽

Drug Reactions ◽

Drug Eruptions ◽

Wide Range ◽

Mucosal Involvement ◽

History Of

Background: Adverse drug reactions are unwanted pharmacodynamic effects following administration of a drug. With an increase in number of newer drugs adverse drug reactions have become very common in recent times. Among them cutaneous reactions have been steadily gaining importance and constitute a major proportion of all the adverse drug reactions.Methods: This observational study was conducted at Sri Siddhartha Medical College and Hospital Tumkur, Karnataka, India, involving 73 patients with cutaneous adverse drug reaction (CADR) during November 2016 to May 2018. The aim of the study is to identify the causal drug and categorised into definite/probable/possible Naranjo Algorithm scale was used.Results: The mean age of study participants was 35 years. Majority of cases observed had fixed drug eruptions (FDE: 37%), followed by maculo papular drug reaction (MPDR: 26%). Antimicrobials (42%), non-steroidal anti-inflammatory drugs (NSAIDs: 26%), anticonvulsants (9.5%) were commonly implicated drugs causing CADR. Among those with FDE, definite causality was highest for NSAIDs (9.6%) predominantly paracetamol whereas in MPDR definite causality was noted with anti-tubercular drugs (rifampicin 1.4%) and probable causality was highest for cephalosporins (5.5%) predominantly cefpodoxime. In present study it was observed female patient aged ≥35 years showed statistically significant mucosal involvement and past history of CADRs.Conclusions: A wide range of clinical spectrum of CADRs ranging from FDE to serious toxic epidermal necrolysis was observed. Most of these drug eruptions were caused by antimicrobials. Eliciting past history of CADRs with causal association will help to prevent and manage cases in a better way.

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