Fixed drug eruptions: causing drugs, pattern of distribution and causality assessment in a leading tertiary care hospital

Rahul Saini, Bhawana Sharma, Prem Kumar Verma, Seema Rani, Garima Bhutani


Background: It is bitter truth that there is no drug in this world which is without an adverse drug reaction (ADR). After the clinical trials when the drug comes in market or when it is taken by variety of population then actual reality of the drug comes out about its efficacy and adverse drug reactions. Fixed drug eruption is also one such type of ADR in which a specific type of lesions occurs over the skin after the drug is taken.

Methods: We have conducted a clinical, observational study, in BPS Government Medical College, Khanpur Kalan, Sonepat, Haryana, India over a period of eight months. In that period we have found 159 patients having adverse drug reactions. Patients of both genders, under all age group were included in the study.

Results: Out of 159 adverse drug reactions reports 69 (43.39%) were cutaneous adverse drug reaction report, 45 (28.30%) cases were of fixed drug eruption (FDE). Out of these 45 cases seen, there were 4 males (8.88%) and 41 females (91.11%). Flouroquinolone antibiotics like ciprofloxacin, ofloxacin and norofloxacin were the most common drugs causing fixed drug eruption followed by nitroimadazole antibiotic like metronidazole, tinidazole and NSAIDS like diclofenac, paracetamol and meftal spas in our study. FDE are more common in upper limbs extremities followed by lower limb extremities than face and trunk. Causality assessment was done with the help of WHO UMC scale and we found that association was possible in all the cases.

Conclusions: Fixed drug eruptions are one of the major types of adverse drug reactions and should be assessed and reported.


Pharmacovigilance, FDE, ADR

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