Diclofenac is a widely used non-steroidal anti-inflammatory drug (NSAID). The most common reported adverse drug reactions (ADRs) of diclofenac are nausea, vomiting, epigastric pain, headache and dizziness. Fixed drug eruption (FDE) is also one ADR due to diclofenac, which is even though not uncommon, in this case the severity is very high. That has made us to focus on this case. A 52-year-old male patient attended the skin OPD (outpatient department) with multiple erythematous patches over face, neck, upper limbs and lower limbs which were started after taking diclofenac for sprain injury. After complete history, the patient said he had similar complaints in the past for same drug. Patient started showing improvement after stopping diclofenac. Completely recovered after 10 days.
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.
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