Among cutaneous adverse drug reactions, fixed drug eruption is the most common cutaneous drug reaction among the Indian population. The drugsmost commonly implicated in fixed drug eruption are analgesics and antibiotics. Here, we report a case of fixed drug reaction caused by rabeprazole.Â Â Â

D, Amita

O, Balaji

Patil, Navin

English

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Vol 10, Issue 5, 2017Online - 2455-3891 Print - 0974-2441RABEPRAZOLE-INDUCED FIXED DRUG ERUPTION: A RARE CASE REPORTBALAJI O1, AMITA D1, NAVIN PATIL2*1Department of Pharmacology, Kasturba Medical College, Manipal, Karnataka, India. 2Department of Medical Oncology, Kasturba Medical College, Manipal, Karnataka, India. Email: navin903@gmail.comReceived: 16 January 2016, Revised and Accepted: 28 February 2017ABSTRACTAmong cutaneous adverse drug reactions, fixed drug eruption is the most common cutaneous drug reaction among the Indian population. The drugs most commonly implicated in fixed drug eruption are analgesics and antibiotics. Here, we report a case of fixed drug reaction caused by rabeprazole.Keywords: Fixed drug eruption, Rabeprazole, Proton-pump Inhibitor, Naranjo’s scale.INTRODUCTIONAn adverse reaction is defined as an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product. Most common among them is cutaneous adverse drug reactions [1] with fixed drug eruption being the most common cutaneous drug reaction among the Indian population [2]. The drugs most commonly implicated in fixed drug eruption are analgesics and antibiotics [2]. Here, we report a case of fixed drug reaction caused by rabeprazole.CASE REPORTInformed consent was obtained from the patient. A 26-year-old male came with complaints of rounded reddish erythematous bright red macular patches over the right thumb of size 1 cm × 1 cm, right index finger of size 0.5 cm × 0.5 cm, and mucosa of the upper lip of size 2 cm × 2 cm with edematous plaques. Patient also had tingling and burning sensation with itching. Past history of patient reveals on and off fever, cough, and expectoration since 3 months and treatment with paracetamol and rabeprazole. Patient said similar lesion appeared over his index finger and it subsided after he finished his course of treatment. He did not report it to a physician. There is no other significant medical history or exposure to other drugs. Two weeks back, patient was treated for the same condition with Dolo 650 mg thrice daily and rabeprazole 20 mg twice daily. After taking medications for 1 day, the patient developed reddish macules, and doctor advised her to stop rabeprazole. She was then continued with paracetamol, and patient lesion slowly subsided on treatment. Rechallenge was not performed as the patient did not give consent, and causality assessment was performed using Naranjo’s scale. Severity and preventability assessment was performed using Hartwig’s scale and Thornton’s scale, respectively.DISCUSSIONIn 1894, Brocq coined the term fixed drug eruption (“erytheme  pigmente fixe”) after investigating three patients on antipyrine presenting with erythematous pigmented eruptions [3]. A fixed drug eruption is a skin lesion characterized by bright red, rounded erythematous macules with edematous plaques that appear at the same site within 30 minutes to 12 hrs after the administration of the causative drug. Lesions are usually solitary initially and then later after repeated exposure can present as multiple lesions occurring at the same site of increasing size as well as new lesions over other sites. Common sites of involvement include hand, feet, genitalia, periorbital, perioral, and perineal areas [4].Pathogenesis mainly involves infiltration of the CD8 cells into the epidermis, and an intellectual memory is created. When the offending drug is administered, these cytotoxic cells gets activated and produce a cascade of inflammatory cytokines mainly interferon-alpha [3]. These cytokines cause apoptosis of keratinocytes leading to epidermal injury presenting as eczema, macules, blisters, and plaques. Acute stage is characterized by epidermal necrosis progressing with dermal lymphocytic infiltration ultimately resulting in deposition of melanin in epidermis in chronic lesions [4].Many drugs cause fixed drug eruptions, and common ones are included in Table 1 [4]. Rabeprazole is a substituted benzimidazole, a proton-pump inhibitor [5]. It is mainly used in the treatment of peptic ulcer, gastroesophageal disorder, and also in Helicobacter pylori infections. It causes adverse effects such as diarrhea, headache, dizziness, and confusion with the prevalence of cutaneous reactions ranging from 0.5% to 1.5%. Cutaneous reactions present as angioedema, urticaria, anaphylaxis, maculopapular rashes, hyperpigmentation, erythema multiforme and erythroderma, exfoliative dermatitis, and bullous eruption [4].© 2017 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2017.v10i5.17123Case ReportTable 1: Common drugs causing fixed drug eruptionsSulfonamides (cotrimoxazole)TetracyclinesPenicillinErythromycinClarithromycinMetronidazoleCiprofloxacinRifampicinNSAIDsBarbiturates, benzodiazepinesLamotrigineFluconazoleCetirizineOmeprazole and lansoprazoleACE inhibitorsHormonal preparationsNSAIDs: Nonsteroidal anti-inflammatory drugs, ACE: Angiotensin-converting enzyme14Asian J Pharm Clin Res, Vol 10, Issue 5, 2017, 13-14 Balaji et al. As per literature, only a few cases of fixed drug eruptions have been reported with proton-pump inhibitors mainly omeprazole [6-9]. In our patient, rabeprazole was given and other drugs causing it was ruled out. Causality, severity, and preventability assessment as per Naranjo’s, Hartwig’s, and Thornton’s scale was found to be probable, mild severity, and not preventable, respectively (Table 2) [10].CONCLUSIONSince a probable causal relationship is established and rabeprazole being a commonly prescribed drug for peptic ulcer disease, history of previous drug exposure and any cutaneous adverse drug reactions to proton-pump inhibitors should be recorded. Immediate discontinuation of drug is warranted if the patient complaints of fixed drug eruption and proper treatment should be given. This case also suggests increased need for improved post-marketing surveillance to combat the emergence of new adverse drug reactions attributed to changing trends in drug utilization. Further retrospective as well prospective clinical trials can be undertaken to find out the exact incidence and prevalence of fixed drug eruptions with proton-pump inhibitors in future in India.REFERENCES1. Breathnach SM. Adverse cutaneous reactions to drugs. Clin Med (Lond) 2002;2(1):15-9.2. Hiware S, Shrivastava M, Mishra D, Mukhi J, Puppalwar G. Evaluation of cutaneous drug reactions in patients visiting out patient departments of Indira Gandhi Government Medical College and Hospital (IGGMC and H), Nagpur. Indian J Dermatol 2013;58(1):18-21.3. Benedix F, Schilling M, Schaller M, Röcken M, Biedermann T. A young woman with recurrent vesicles on the lower lip: Fixed drug eruption mimicking herpes simplex. Acta Derm Venereol 2008;88(5):491-4.4. Breathnach SM. Drug reactions. In: Burns DA, Breathnach SM, Cox NH, Griffiths CE, editors. Rook’s Textbook of Dermatology. 8th ed. West Sussex: Blackwell Publishing Ltd.; 2010. p. 75.1-75.77.5. Patel AR, Patel PR, Vora CN, Patel ND, Patel JK. Formulation, process parameters optimization and evaluation of delayed release tablets of rabeprazole sodium. Int J Pharm Pharm Sci 2010;2(3):144-56.6. Kepekci Y, Kadayifci A. Fixed drug eruption in hands caused by omeprazole. Int J Clin Pharmacol Ther 1999;37(6):307-9.7. Kai Y, Okamoto O, Fujiwara S. Fixed drug eruption caused by three unrelated drugs: Promethazine, pethidine and omeprazole. Clin Exp Dermatol 2011;36(7):755-8.8. Morais P, Baudrier T, Mota A, Cunha AP, Cadinha S, Barros AM, et al. Nonpigmented fixed drug eruption induced by esomeprazole. Cutan Ocul Toxicol 2010;29(3):217-20.9. Savin JA. Current causes of fixed drug eruption in the UK. Br J Dermatol 2001;145:667-8.10. Balaji O, Navin P, Avinash A, Amod T. Cefuroxime-induced thrombocytopenia: It’s just not in the ring? Asian J Pharm Clin Res 2016;9(5):1-2.Table 2: Adverse drug reaction assessmentNaranjo’s scale ProbableHartwig’s scale Mild severityThornton’s scale Not preventable

Rabeprazole induced Fixed Drug Eruption: A rare case report

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Rabeprazole induced Fixed Drug Eruption: A rare case report

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