Spectrum Of Cutaneous Adverse Drug Reactions Research Articles

Evaluation of Cutaneous Adverse Drug Reactions Reported in a Teaching Hospital of Coastal Andhra

Adverse drug reactions (ADR) can be manifested in different forms, among these cutaneous adverse drug reactions (CADRs) are the commonest. They have been steadily gaining importance and constitute a major proportion of all ADRs. As available data on CADRs is very less, more research is required to have reliable data, hence the current study was undertaken. This prospective study was carried out to evaluate the age and gender distribution, presenting complaints, spectrum of CADRs, causative drugs, causality, severity, and outcomes in patients with or suspected CADRs attending the department of Dermatology of Konaseema Institute of Medical Sciences & Research Foundation Hospital between January 2014 and June 2015. In cooperation with the Dermatologist, patients’ reactions were analyzed based on morphology, and laboratory investigations. Causality was assessed as per the World Health Organization- Uppsala Monitoring Centre (WHO-UMC)causality assessment scale. Modified Hartwig and Siegel Scale was used for the severity assessment of reactions. CADRs occurred most commonly in the 31-40 years age group (32%) with no sign of the difference in both sexes. The most common complaint of CADRs by the patients was skin rash (42%) anddiagnoses were Erythematous drug eruption (ERDE) and Fixed drug eruption (FDE) (28%). The commonest causative drug categories were antimicrobials (52%) and Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (24%).Among antimicrobials, ciprofloxacin, and in NSAIDs, diclofenac were the commonest causative drugs. In causality, majority of the cases were under possible category(42%). Most of the reactions were mild (46%), and moderate (46%) in severity. The majority of the cases showed good recovery without any mortality or disability. The limitations of this study were the relatively small sample size, inability to confirm the particular causative drug in majority of the patients. Future research should focus on the genetic factors concerning to CADRs and molecular-level evaluation should be done for a better understanding of the pathophysiology of various ADRs.

Cutaneous adverse drug reactions from a teaching hospital in Bengaluru: An observational study to determine the spectrum and outcome

Background: Cutaneous adverse drug reactions (CADRs) are frequent manifestations of drug reactions that can lead to discontinuation of treatment, impaired quality of life and increased economic burden. Knowledge of drugs causing CADRs help in choosing safer drugs. Aims and Objectives: To determine the clinical spectrum, causality, severity, and preventability of CADRs. Materials and Methods: An observational study conducted from 2012 to 2016 to analyze the CADRs reported from Dermatology Department, of Bangalore Medical College and Research Institute to adverse drug reaction (ADR) Monitoring Center. Patient’s demographics, clinical and drug data, details of ADRs were collected as per CDSCO form. Causality, severity, and preventability were assessed using relevant scales. Results: Out of 809 ADRs reported, 230 were CADRs. Male preponderance (56%) was seen. Age group of 21-40 years (57%) was most affected. Maximum CADRs were seen with beta-lactam class of drugs (20%), followed by nonsteroidal anti-inflammatory drugs (17.4%) and antiepileptics (13.5%). Maculopapular rash (26%) was the most common CADR. Stevens–Johnson syndrome (SJS) contributed to the majority of severe CADRs. Causative drug was withdrawn in 90% of cases. Causality assessment indicated 80.4% as probable and 19.6% as possible cases. 81% of CADRs were of moderate severity, and only 6% were severe like SJS. 11% were “definitely preventable” CADRs. Conclusion: Wide clinical spectrum of CADRs was observed. Definitely preventable CADRs were due to improper recording of history of drug allergy and wrong choice of self-medication by the patients. Inconsistent with the previous literature, the incidence of diclofenac-induced SJS was found high.

A study of clinical patterns and causative agents of adverse cutaneous drug reactions

Background: Cutaneous eruptions are the most frequently reported adverse reactions to drugs. The pattern of cutaneous adverse drug reactions (CADRs) and the causative drugs keeps changing every year. Objective: The study was designed to ascertain the different clinical patterns of CADRs and to determine the causative agents. Materials and Methods: A prospective observational nonrandomized hospital-based study was carried out over a period of 6 months. The CADRs as observed in the outpatient and inpatient Departments of Dermatology were recorded. Naranjo's algorithm was used to determine the causality assessment. Clinical pattern of these adverse drug cutaneous reactions was studied. Causality assessment was done with the help of Naranjo's algorithm. Results: A total of fifty patients diagnosed to have CADRs were included in the study. The most common type of CADRs was urticaria (30%) followed by fixed drug eruption (FDE) (24%) and maculopapular eruption (12%). Antimicrobial agents (AMAs) (48%) were responsible for majority of the detected reactions, followed by nonsteroidal anti-inflammatory drugs (24%), antihypertensives (8%), and antiepileptics (4%). A total of 41 reactions (82%) showed probable causal association, 4 reactions had possible association (8%), and 5 cases of cutaneous drug reaction (10%) showed definite causal association with the drug. Conclusion: A wide clinical spectrum of CADRs ranging from FDE to mild maculopapular rash to serious Stevens–Johnson syndrome was observed. Most of these drug eruptions were caused by AMAs. The occurrence of CADRs in the present study was in concurrence to various studies conducted in India.