Case Report: Ofloxacin-induced fixed drug eruption

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Varma" }, { "@type": "Person", "name": "Ashish R. Varma" }, { "@type": "Person", "name": "Sakshi P. Arora" }, { "@type": "Person", "name": "Waqar M. Naqvi" } ], "publisher": { "@type": "Organization", "name": "F1000Research", "logo": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 480, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 1200, "width": 150 }, "description": " Background Fixed Drug Eruption (FDE) is a rare form of drug-induced dermatoses that appears as well-defined, erythematous patches occurring within hours of medication’s administration with or without blistering and resolves with post-inflammatory residual hyperpigmentation. Case presentation A 50-year-old male patient visited the outpatient department with chief complaints of burning micturition, increased urine frequency, and high-grade fever with chills lasting three days. Blood and urine investigations indicated leukocytosis and remnants of pus cells, respectively, confirming the diagnosis of urinary tract infection intervened with a tablet ofloxacin. Two hours after drug consumption, intense itching was noticed over the body, which soon progressed to blackening discoloration; blisters developed with a burning sensation over the webs of the palm and on the arm, with hyperpigmentation of the lower lip. Furthermore, painful patches with serous discharge developed in the oral cavity and penile tip. He had encountered a similar episode seven years before, which confirmed the diagnosis of fixed drug eruption (FDE). Immediate treatment included injectable steroids, antihistamines, cephalosporin antibiotics, and intravenous fluids with discontinuation of the ofloxacin drug. He adhered well to the treatment and had a remarkable improvement after 72 hours with residual hyperpigmentation, following which, the patient was advised to avoid similar medicine in the future to prevent a recurrence. Conclusions This case report concludes that the adverse drug reactions should be considered mandatorily with antibiotic audits on a regular basis to ensure that the course of treatment is appropriate and adequate, and any inappropriate reaction should be reported immediately. The rationality of the treatment and inappropriate prescriptions must be reported. 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Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Case Report Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] Anuj R. Varma 1 , Ashish R. Varma 2 , Sakshi P. Arora https://orcid.org/0000-0002-2706-3461 3 , Waqar M. Naqvi https://orcid.org/0000-0003-4484-8225 3,4 Anuj R. Varma 1 , Ashish R. Varma 2 , Sakshi P. Arora https://orcid.org/0000-0002-2706-3461 3 , Waqar M. Naqvi https://orcid.org/0000-0003-4484-8225 3,4 PUBLISHED 11 Mar 2024 Author details Author details 1 Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, India 2 Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, India 3 Faculty of Interdisciplinary Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, India 4 Department of Physiotherapy, College of Health Sciences, Gulf Medical University, Ajman, United Arab Emirates Anuj R. Varma Roles: Conceptualization, Data Curation, Formal Analysis, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Ashish R. Varma Roles: Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Sakshi P. Arora Roles: Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Waqar M. Naqvi Roles: Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Background Fixed Drug Eruption (FDE) is a rare form of drug-induced dermatoses that appears as well-defined, erythematous patches occurring within hours of medication’s administration with or without blistering and resolves with post-inflammatory residual hyperpigmentation. Case presentation A 50-year-old male patient visited the outpatient department with chief complaints of burning micturition, increased urine frequency, and high-grade fever with chills lasting three days. Blood and urine investigations indicated leukocytosis and remnants of pus cells, respectively, confirming the diagnosis of urinary tract infection intervened with a tablet ofloxacin. Two hours after drug consumption, intense itching was noticed over the body, which soon progressed to blackening discoloration; blisters developed with a burning sensation over the webs of the palm and on the arm, with hyperpigmentation of the lower lip. Furthermore, painful patches with serous discharge developed in the oral cavity and penile tip. He had encountered a similar episode seven years before, which confirmed the diagnosis of fixed drug eruption (FDE). Immediate treatment included injectable steroids, antihistamines, cephalosporin antibiotics, and intravenous fluids with discontinuation of the ofloxacin drug. He adhered well to the treatment and had a remarkable improvement after 72 hours with residual hyperpigmentation, following which, the patient was advised to avoid similar medicine in the future to prevent a recurrence. Conclusions This case report concludes that the adverse drug reactions should be considered mandatorily with antibiotic audits on a regular basis to ensure that the course of treatment is appropriate and adequate, and any inappropriate reaction should be reported immediately. The rationality of the treatment and inappropriate prescriptions must be reported. READ ALL READ LESS Keywords Fixed Drug Eruption, Ofloxacin, Dermatoses, Fluoroquinolone, Urinary Tract Infection Corresponding Author(s) Waqar M. Naqvi ( [email protected] ) Close Corresponding author: Waqar M. Naqvi Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Varma AR et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Varma AR, Varma AR, Arora SP and Naqvi WM. Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :181 ( https://doi.org/10.12688/f1000research.142368.1 ) First published: 11 Mar 2024, 13 :181 ( https://doi.org/10.12688/f1000research.142368.1 ) Latest published: 11 Mar 2024, 13 :181 ( https://doi.org/10.12688/f1000research.142368.1 ) Introduction Fixed drug eruption (FDE) or “eruption érythémato-pigmentée fixe” was initially reported and described by Bourns in 1889 and Brocq in 1894, respectively. 1 FDE is a specific type of drug-induced dermatoses that emerges as clearly defined, erythematous (eryth) patches occurring with or without blisters within hours of the administration of the triggering medication and resolves with post inflammatory persisting hyperpigmentation. 2 When exposed again to the same or a comparable class of medications, it typically occurs at the same area of the skin or mucous membrane. 2 Ofloxacin (OF), a fluoroquinolone (FQ) of second generation, is quite efficient against a variety of bacterial infections with some adverse effects that include gastrointestinal disorders, skin reactions, and neurological reactions. 3 They are commonly used antibiotics that can cause dermatological adverse drug reactions (ADRs) in about 1-2% of individuals. 4 Rare hypersensitivity events due to OF include itching, skin rashes, urticaria, erythema and shock, and their frequency ranges from 0.4% to 2%. 5 FDE can affect people of any age, however it most frequently affects individuals with documented median ages ranging from 35 to 60 years, and both men and women are equally susceptible to it. 1 Recurrence of FDE is regulated by CD8+ memory T-cells, which are found in the basal layer of the epidermis of dormant FDE lesions. 6 These cells drift upwards in the epidermis within 24 hours of ingesting the triggering medicine, 6 generate cytokines such interferon-gamma and TNF-alpha (1), acquire the features of a natural killer cell, and express the cytotoxic chemicals granzyme B and perforin along with cell surface molecule CD56. 6 This natural killer feature that the cells acquired during FDE subsides once the acute stage of the condition has passed and they remain dormant in the epidermis in the region of prior eruption for a long time. 6 Bullous FDE, however, is not frequently recorded. Thus, this case report emphasizes a rare instance of FDE brought on by the administration of the drug OF. Case report The case report was amended according to the CARE guidelines. Patient information A 50-year-old South-Asian male patient presented at the Acharya Vinoba Bhave Rural Hospital, Sawangi, India, with the main complaints of burning micturition, increased frequency of urination, nausea, vomiting, pain in low back and high-grade fever with chills lasting three days at the medicine outpatient department (OPD). The patient described a past history of urinary tract infection (UTI) seven years before for which he had taken unknown medicine that he was not able to recollect that caused him intense itching along with blackening of skin of upper and lower limbs and gluteal region along with development of blisters. Clinical findings and diagnostic assessment On examination, the patient was coherent, well-oriented and stable with blood pressure 110/70 mmHg, for investigations the patient’s blood and urine sample were sent for laboratory investigation, which revealed increased C-reactive protein, raised blood creatinine, leukocytosis with neutrophilia and increased number of pus cells that confirmed the diagnosis of UTI caused by the bacteria Escherichia coli. As the bacteria was found sensitive to the drug OF it was prescribed to the patient along with the advice of consumption of plenty of water. The first dose of OF was taken by the patient on the same evening. At midnight, after 2 hours of drug consumption, intense itching started all over the body, especially involving upper and lower limbs and gluteal region, which soon progressed to blackening of skin on these parts. Additionally, physical examination revealed development of five blisters with burning sensation measuring 2–2.5 cm in diameter that were well circumscribed having an erythematous base over webs of palm ( Figure 1 ) and on arm with negative Nikolsky sign 7 along with hyperpigmentation of the lower lip. Furthermore, the patient developed painful erosions with serous discharge formation in oral cavity ( Figure 2 ), penile tip, and prepuce ( Figure 3 ). Based on the above presentation following the administration of the drug OF, the patient was referred to dermatology OPD where a diagnosis of fixed drug eruption was confirmed. Figure 1. Blister on web of the palm can be seen with peeling of skin. Figure 2. Involvement of oral cavity and lips with painful ulceration, induration, and serous discharge. Figure 3. Edematous prepuce with induration and discharge from penile tip. Therapeutic intervention Before commencing medical intervention, the objective of the treatment was described to the patient and written informed consent was obtained. Following which immediate medical treatment was started with injectable steroids, injection ceftriaxone and levocetirizine, intravenous fluids, and topical betamethasone butyrate propionate ointment along with discontinuation of OF. Follow-up and outcomes The patient adhered well to the above mentioned treatment as the outcomes of the intervention demonstrated subsiding of itching after 3 to 4 hours, oral and penile ulceration healed in 48 hours and overall condition of the patient improved after 72 hours with the presence of residual hyperpigmentation. Patient was advised to avoid similar medicine in future to avoid recurrence. Discussion OF is a FQ prescribed to treat diseases of the prostate, skin, urinary system, and lungs caused due to bacteria. Anaphylactic responses and incidences of shock related to hypersensitivity have been documented during post-marketing surveillance. 8 The terminology FDE indicates formation of eryth patches as a consequence of administration of a medication. Based on the location of the lesion and their clinical characteristics, various morphological forms of FDE, such as pigmenting, non-pigmenting, and bullous FDE, are known. 3 According to a systematic review, antibiotics are responsible for 28% of ADRs, and the estimated prevalence rate of ADRs caused by ofloxacin is 4.27%. 9 The basic presentation of the OF-related FDE seen in this case was intense itching all over the body. In particular, it involved upper and lower limbs and gluteal region, which soon progressed to blackening of skin on these parts. Development of blisters with burning sensation were well circumscribed with an erythematous base over webs of palm and on arm along with hyperpigmentation of the lower lip, and painful erosions with serous discharge formation in oral cavity, penile tip and prepuce. Development of blisters made the condition of this patient more severe. These related findings were published in a study that characterized generalized bullous FDE as standard FDE lesions occur at three of six different anatomic regions with blisters covering and accounting for not less than 10% surface area of the body. It was referred as Stevens-Johnson syndrome, which was basically differentiated on the basis of morphological characteristics of the eruption and the site of onset. 10 The pathophysiological process consists of cell-mediated cytotoxic reaction, which is antibody-dependent, and CD8+ effector or memory T cells play a critical role in reactivating the reaction when exposed to the triggering medication again, however the precise mechanism is still unknown. 3 However, the evidence indicates that these cells are primarily responsible for the occurrence of localized tissue destruction in FDE, and arousal of these cells triggers skin lesion. 1 , 3 OF and other quinolones can cause both the IgE-mediated as well as delayed form of hypersensitivity reaction. 2 , 11 In this case the patient was diagnosed with UTI for which OF was prescribed that resulted in FDE. Similarly, a previous review demonstrated various ADRs of OF that involved angioedema when given in case of diarrhea, 9 cutaneous vasculitis in diabetic foot and UTI, intense erythema with sub-corneal pustulation, fever, and neutrophil leukocytosis in bronchitis and pharyngitis. 9 The ADRs improved when OF that was being administered was discontinued, as there was no other cause that might have independently caused the reaction, and it was therefore, confirmed to be an FDE. Treatment for these reactions should primarily focus on cessation of the triggering drug and consumption of topical corticosteroids or antihistamines, and cephalosporin antibiotics. 3 In this case, injectable steroids, injection ceftriaxone, and levocetirizine and intravenous fluids, topical betamethasone butyrate propionate ointment along with discontinuation of OF was commenced. When the patient returned for follow-up one month later, the lesions had subsided and the patient had responded well to the treatment. The primary take away lessons involve strict avoidance of the culprit drug, which can protect the patient from recurrence, for diagnosis of fixed drug reactions the patient can be rechallenged by oral or patch test with the offending drug causing eruptions repeatedly at the identical skin site (that is fixed), and a note can be written on the discharge card with mention of offending drug molecule along with patient education for future prescription by other doctors. Conclusions This case report highlights fixed drug eruption caused due to ofloxacin drug during treatment of UTI and concludes that all hospitals should be mandated to track ADRs along with conduction of antibiotic audits on a regular basis to ensure that the course of treatment is appropriate and adequate, and any inappropriate prescription should be reported. A regular antibiotic audit must be done to check the rationality of the treatment and in case of inappropriate prescribing, errors must be reported. Additionally, ofloxacin must be included in the differential diagnosis of FDE and healthcare providers need to be made aware of illogical drug combinations. Patient perspective I had this tendency of increased urination for 15 years. But this time it was with burning micturition and fever. I visited a nearby hospital. They admitted me and initiated with some medication. After two hours of consuming my first dosage, I felt itching everywhere on my body. Then I noticed weird black stains over my lower lip and palms, so I immediately called the medical staff on duty who immediately took my concern into consideration and called for further help. Again, I got prescribed with some other medications and after three days, I was relieved a bit with the symptoms. Consent Written informed consent for publication of clinical details and images was obtained from the patient. Data availability All data underlying the results are available as part of the article and no additional source data are required. References 1. Anderson HJ, Lee JB: A Review of Fixed Drug Eruption with a Special Focus on Generalized Bullous Fixed Drug Eruption. Medicina. 2021; 57 : 925. PubMed Abstract | Publisher Full Text | Free Full Text 2. Kameswari PD, Selvaraj N, Adhimoolam M: Fixed drug eruptions caused by cross-reactive quinolones. J Basic Clin Pharm. 2014; 5 : 54–55. PubMed Abstract | Publisher Full Text | Free Full Text 3. Gohel KH, Shah KV, Patel S, et al. : Ofloxacin-induced fixed drug eruptions. Int. J. Integr. Health Sci. 2020; 8 : 22. Publisher Full Text 4. Jain SP, Jain PA: Bullous Fixed Drug Eruption to Ciprofloxacin: A Case Report. J. Clin. Diagn. Res. 2013; 7 : 744–745. PubMed Abstract | Publisher Full Text | Free Full Text 5. Ramineni HB, Eluri P, Vipparla K, et al. : Ofloxacin induced hypersensitivity reaction. Int. J. Res. Med. Sci. 2017; 3 : 349–351. Publisher Full Text 6. Mizukawa Y, Yamazaki Y, Shiohara T: In vivo dynamics of intraepidermal CD8+ T cells and CD4+ T cells during the evolution of fixed drug eruption. Br. J. Dermatol. 2008; 158 : 1230–1238. PubMed Abstract | Publisher Full Text 7. Maity S, Banerjee I, Sinha R, et al. : Nikolsky’s sign: A pathognomic boon. J. Family Med. Prim. Care. 2020; 9 : 526–530. PubMed Abstract | Publisher Full Text | Free Full Text 8. Sarkar MK, Dey S: A Fixed-Dose Combination of Ofloxacin-Ornidazole Induced Fixed Drug Eruption: A Case Report. Cureus. 2023; 15 : e35630. eCollection 2023 Mar. PubMed Abstract | Publisher Full Text | Free Full Text 9. Kamdi AS, Kokane SD, Bohra PN, et al. : Systematic review of adverse drug reactions of ofloxacin. International Journal of Basic & Clinical. Pharmacology. 2018; 7 : 2277–2280. Publisher Full Text 10. Cho Y-T, Lin J-W, Chen Y-C, et al. : Generalized bullous fixed drug eruption is distinct from Stevens-Johnson syndrome/toxic epidermal necrolysis by immunohistopathological features. J. Am. Acad. Dermatol. 2014; 70 : 539–548. PubMed Abstract | Publisher Full Text 11. Sánchez-Morillas L, Rojas Pérez-Ezquerra P, González Morales ML, et al. : Fixed drug eruption due to norfloxacin and cross-reactivity with other quinolones. Allergol. Immunopathol. 2013; 41 : 60–61. PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 11 Mar 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, India 2 Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, India 3 Faculty of Interdisciplinary Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, India 4 Department of Physiotherapy, College of Health Sciences, Gulf Medical University, Ajman, United Arab Emirates Anuj R. Varma Roles: Conceptualization, Data Curation, Formal Analysis, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Ashish R. Varma Roles: Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Sakshi P. Arora Roles: Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Waqar M. Naqvi Roles: Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 11 Mar 2024, 13:181 https://doi.org/10.12688/f1000research.142368.1 Copyright © 2024 Varma AR et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Varma AR, Varma AR, Arora SP and Naqvi WM. Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :181 ( https://doi.org/10.12688/f1000research.142368.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 11 Mar 2024 Views 0 Cite How to cite this report: Özkaya E. Reviewer Report For: Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :181 ( https://doi.org/10.5256/f1000research.155914.r287834 ) The direct URL for this report is: https://f1000research.com/articles/13-181/v1#referee-response-287834 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 10 Jun 2024 Esen Özkaya , İstanbul University, İstanbul, Turkey Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.155914.r287834 This is an interesting case report on ofloxacin-induced fixed drug eruption on skin and mucosa. I have the following comments and suggestions for improvement (page numbers refer to the PDF): Page 3, Introduction: Please focus on ... Continue reading READ ALL This is an interesting case report on ofloxacin-induced fixed drug eruption on skin and mucosa. I have the following comments and suggestions for improvement (page numbers refer to the PDF): Page 3, Introduction: Please focus on the background information of ofloxacin-induced fixed drug eruption in the literature. Also, please add information on common clinical forms of quinolone-induced FDE. The last 2 sentences of the introduction need revising to be more specific to the presented case. Move the pathophysiology to the discussion section. Page 3, Patient information: Please add the Fitzpatrick skin type of the patient. Page 3, Clinical findings and diagnostic assessment: Was the patient diagnosed with generalized bullous FDE or not? Please revise accordingly. Include the Naranjo drug reaction probability score of the patient. The diagnosis of FDE needs to be confirmed by systemic or topical provocation. Was a topical provocation test performed? Please add this to the text. Was this the second attack of FDE? Please add the information to the text. Also, include details of any similar episodes in the past. Page 4, Follow-up and outcomes: How long was the patient followed-up for recurrences? What does “similar medicine” mean? Please be more specific. Page 5, Discussion: Was the patient diagnosed with generalized bullous FDE or not? Please add this to the discussion along with the reasons. Please revise “It was referred as Stevens-Johnson syndrome, which was basically differentiated on the basis of morphological characteristics of the eruption and the site of onset.” as “It was differentiated from Stevens-Johnson syndrome on the basis of morphological characteristics of the eruption, such as ………, and the site of onset, particularly, ……” Page 5, Discussion: Please discuss other quinolone-induced FDEs published in the literature along with their cross-reactivity. Was this patient checked for cross-reactivity to other quinolones? Page 4, Conclusion: Please revise the conclusion to focus on the major outcomes for this patient. What does this case add to the literature, and why is it significant? Is the background of the case’s history and progression described in sufficient detail? Partly Are enough details provided of any physical examination and diagnostic tests, treatment given and outcomes? Partly Is sufficient discussion included of the importance of the findings and their relevance to future understanding of disease processes, diagnosis or treatment? Partly Is the case presented with sufficient detail to be useful for other practitioners? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Allergic contact dermatitis, fixed drug eruption I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Özkaya E. Reviewer Report For: Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :181 ( https://doi.org/10.5256/f1000research.155914.r287834 ) The direct URL for this report is: https://f1000research.com/articles/13-181/v1#referee-response-287834 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 11 Mar 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 11 Mar 24 read Esen Özkaya , İstanbul University, İstanbul, Turkey Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Özkaya E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 10 Jun 2024 | for Version 1 Esen Özkaya , İstanbul University, İstanbul, Turkey 0 Views copyright © 2024 Özkaya E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is an interesting case report on ofloxacin-induced fixed drug eruption on skin and mucosa. I have the following comments and suggestions for improvement (page numbers refer to the PDF): Page 3, Introduction: Please focus on the background information of ofloxacin-induced fixed drug eruption in the literature. Also, please add information on common clinical forms of quinolone-induced FDE. The last 2 sentences of the introduction need revising to be more specific to the presented case. Move the pathophysiology to the discussion section. Page 3, Patient information: Please add the Fitzpatrick skin type of the patient. Page 3, Clinical findings and diagnostic assessment: Was the patient diagnosed with generalized bullous FDE or not? Please revise accordingly. Include the Naranjo drug reaction probability score of the patient. The diagnosis of FDE needs to be confirmed by systemic or topical provocation. Was a topical provocation test performed? Please add this to the text. Was this the second attack of FDE? Please add the information to the text. Also, include details of any similar episodes in the past. Page 4, Follow-up and outcomes: How long was the patient followed-up for recurrences? What does “similar medicine” mean? Please be more specific. Page 5, Discussion: Was the patient diagnosed with generalized bullous FDE or not? Please add this to the discussion along with the reasons. Please revise “It was referred as Stevens-Johnson syndrome, which was basically differentiated on the basis of morphological characteristics of the eruption and the site of onset.” as “It was differentiated from Stevens-Johnson syndrome on the basis of morphological characteristics of the eruption, such as ………, and the site of onset, particularly, ……” Page 5, Discussion: Please discuss other quinolone-induced FDEs published in the literature along with their cross-reactivity. Was this patient checked for cross-reactivity to other quinolones? Page 4, Conclusion: Please revise the conclusion to focus on the major outcomes for this patient. What does this case add to the literature, and why is it significant? Is the background of the case’s history and progression described in sufficient detail? Partly Are enough details provided of any physical examination and diagnostic tests, treatment given and outcomes? Partly Is sufficient discussion included of the importance of the findings and their relevance to future understanding of disease processes, diagnosis or treatment? Partly Is the case presented with sufficient detail to be useful for other practitioners? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Allergic contact dermatitis, fixed drug eruption I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Özkaya E. Peer Review Report For: Case Report: Ofloxacin-induced fixed drug eruption [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :181 ( https://doi.org/10.5256/f1000research.155914.r287834) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-181/v1#referee-response-287834 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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