Original Research Article DOI: 10.18231/2581-4729.2019.0018 IP Indian Journal of Clinical and Experimental Dermatology, January-March, 2019;5(1):85-88 85 A study of fixed-drug reactions at a rural-based tertiary care center, Gujarat Nishit Surti 1 , Trusha Patel 2 , Aishni Shah 3 , Dhruv Patel 4 , Rita Vora 5,* 1 Assistant Professor, 2 3 rd Year Resident, 3,4 1 st Year Resident, 5 Senior Professor, 1-5 Pramukh Swami Medical College, Karamsad, Anand, Gujarat, India *Corresponding: Rita Vora Email: ritavv@charutarhealth.org Abstract Introduction: Nowadays, due to the widespread availability of various drugs, adverse cutaneous drug reactions (ACDRs) have become very common. One type of ACDR that dermatologists encounter frequently these days is Fixed-drug reaction (FDR). FDR is a characteristic type of adverse cutaneous reaction, which occurs at the same site whenever a particular drug is taken. That is why there is a need to identify the drugs causing FDR and to counsel the patients properly to avoid recurrence. Aim and Objective: The aim and objective was to study the demographic details, clinical patterns, and the culprit drugs causing FDR. Setting and Design: We have conducted a cross-sectional, observational study. Materials and Methods: We have conducted an observational cross-sectional study from April 2010 to March 2018 at the Department of Dermatology, Venereology and Leprology at Shree Krishna Hospital, Pramukhswami Medical College, Karamsad, Gujarat, after taking approval from the research ethical committee of our hospital. All patients coming to the skin out patient department who were diagnosed clinically as FDRs were included in the study, irrespective of age and sex. In every case, a detailed history was elicited and proper clinical examination was carried out and it was recorded in a proforma. The data collected was analyzed using proportions, frequencies and chi- square test. All the patients were counseled and given a list of drugs causing FDR to avoid recurrence. Results: In our study, we enrolled 78 patients of FDR in which there were 43 (55.12%) males and 35 (44.88%) females. In these patients, the most frequent condition for which the offending drug was taken was fever (in 18 [23.08%] patients), while the most common complaint after intake of offending drug was pigmented patch (in 32 [41.03%] patients) followed by mucosal lesions (in 20 [25.64%] patients). Overall, antimicrobials (31 [39.74%]) were the most common group of drugs which caused FDR followed by nonsteroidal anti- inflammatory drugs (28 [35.90%]). Considering a single molecule, diclofenac (16 [20.51%]) was the most common drug causing FDR followed by metronidazole (6 [7.69%]) and then cotrimoxazole, fluconazole and ciprofloxacin (5 [6.41%]) each. Conclusion: Among ACDRs encountered in dermatology patients, FDRs form an important part. Antimicrobials are the most common group while diclofenac is the most common drug causing FDR. Keywords: Fixed-drug reaction, Adverse cutaneous drug reactions, Antimicrobials, NSAIDS Introduction Out of all reported adverse drug reactions (ADRs), adverse cutaneous drug reactions (ACDRs) comprise of 10%–30%. 1,2 It occurs in 2%–3% of hospitalized patients. 3 Most of the ACDRs are usually mild and self-limiting, but severe ACDRs such as Stevens–Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms cause significant morbidity and mortality. 4 FDR is defined as a cutaneous drug eruption that recurs at the same site when the same drug is administered and heals with residual hyperpigmentation, which is an indicator of site recognition. 5 If the diagnosis of FDR is missed, it can cause recurrent eruptions whenever the culprit drug is administered again. 6 It can be caused by any medicine but certain drugs like nonsteroidal anti- inflammatory drugs (NSAIDs); antibiotics and anti- epileptics induce reaction in 1%–5% of patients. 7 The lesions of FDR are well defined, round or oval patches with erythema and edema, sometimes accompanied by a blister. With time, it becomes purplish or brownish. Any part of the body can be involved such as face, trunk, upper limbs, lower limbs, genitals and oral mucosa. It is important that skin reactions should be identified at the earliest and documented in the patient records so that their recurrence can be avoided. This study was done to identify the drugs that are responsible for FDR. Materials and Methods We have conducted an observational cross sectional study from April 2010 to March 2018 at the Department of Dermatology, Venereology and Leprology of Shree Krishna Hospital, Pramukhswami Medical College, Karamsad, Gujarat, after taking approval from the research ethical committee of our hospital. All patients coming to the skin out patient department who were diagnosed clinically as FDRs were included in the study, irrespective of age and sex. Written consent of each was taken. In every case, a detailed history was elicited and a thorough clinical examination was carried out. In order to find the causative agent, we enquired in detail about history of drug intake, duration of the lesion, morphology of the eruption, associated mucosal or systemic involvement, temporal correlation of lesions with the drug and improvement of lesions on withdrawal of drug. All other possible etiologies were ruled out and then the diagnosis of ACDR was reached. When two or more drugs were thought to be responsible, the most likely drug was noted and the impression was confirmed when the symptoms reduced on withdrawing the drug. Results We had enrolled 78 patients in our study, which included 43 (55.12%) males and 35 (44.88%) females. 21–