A case report of multiple bullous lesions

 This is a de-identified case report prepared after taking signed informed consent of patient. 

Severe Bullous Drug Eruption Following Local Medication from Unregistered Practitioner: A Case Report

Abstract

We report the case of a South Indian woman in her mid-30s who developed widespread fluid-filled blisters following the use of unprescribed medication from an unregistered practitioner. Prompt recognition, intensive care support, and intravenous corticosteroid therapy led to rapid clinical improvement. This case highlights the importance of early diagnosis and management of severe bullous drug eruptions, as well as the dangers associated with unregulated medications from unqualified sources in the Indian healthcare context.


Keywords: Bullous drug eruption, corticosteroids, unregistered practitioner, adverse drug reaction, case report, India


Introduction

Bullous drug eruptions are rare but potentially life-threatening hypersensitivity reactions, considered among the most severe cutaneous adverse reactions (SCAR) [1]. These reactions are characterized by widespread vesicles, bullae, mucosal involvement, and systemic symptoms [1,2]. Recent studies from India suggest that fixed drug eruptions (FDEs) account for 20–43% of all cutaneous adverse drug reaction patterns, with bullous variants being less common but more severe [3,4].


The incidence of severe bullous drug eruptions such as Stevens-Johnson syndrome (SJS) is estimated at 1.2 to 6 per million patient-years, while toxic epidermal necrolysis (TEN) occurs in 0.4-1.2 per million patient-years [5]. In India, a clinical study of 200 patients with cutaneous drug reactions found that fixed drug eruptions were the most common presentation (30.5%), followed by urticaria (18.5%) and morbilliform rash (18%) [6].


These reactions generally occur as a result of medication use, but there are also other possible causes [1]. One of the major challenges is identifying at a very early stage whether the reaction will be severe and life-threatening [1]. Blisters develop on erythematous skin and coalesce, with at least one mucous membrane typically affected by erosion in addition to the skin [1]. Fever and malaise are common accompanying symptoms [1,7].


Early diagnosis and management are crucial to prevent complications and reduce mortality, which can range from approximately 10% for SJS to almost 50% for TEN [1,8]. Here, we describe a case of a severe bullous eruption triggered by an unknown medication prescribed by an unregistered practitioner in South India.


Case Presentation

A South Indian female in her mid-30s presented to the emergency department with complaints of multiple fluid-filled blisters for the past 12 days. The lesions initially appeared on the trunk and gradually spread to involve the entire body, including both anterior and posterior surfaces, and the oral mucosa.

The patient reported a history of self-medication for fever and body aches approximately 12 days prior to presentation. The medications were obtained from an unregistered local practitioner. There was no prior history of similar dermatological reactions. Within 1–2 days of initiating the medication, the patient developed a rash initially localized to the trunk, which progressively spread to involve the entire body over the subsequent 3–4 days. The initial skin eruption was misinterpreted by family members as chickenpox. Due to prevailing cultural beliefs discouraging individuals from leaving the house within nine days of presumed chickenpox onset, no medical consultation was sought during this period. After nine days, the patient’s son, who resides in Hyderabad, became aware of her condition and promptly brought her to the emergency department for evaluation.


On examination, the patient was alert and oriented. Her vital signs were stable: blood pressure 118/72 mmHg, pulse 88 bpm, respiratory rate 16/min, SpO₂ 98% on room air, and temperature 37.2°C. Dermatological evaluation revealed multiple tense bullae and vesicles, some ruptured, with areas of skin peeling and mucosal involvement suggestive of a severe bullous drug reaction. Nikolsky’s sign was not elicited.











Based on the clinical presentation, a diagnosis of severe bullous drug eruption was made. Differential diagnoses considered included Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized bullous fixed drug eruption, and bullous pemphigoid [1,9].


She was admitted to the intensive care unit for close monitoring and management. Following current management guidelines for severe bullous drug eruptions [10,11], the following measures were implemented:


1. Immediate discontinuation of all suspected medications

2. Maintenance of fluid-electrolyte balance

3. Intravenous corticosteroids

4. Supportive care including wound care for denuded skin areas

5. Monitoring for signs of secondary infection


Over the next 48 hours, the progression of lesions halted, and some began to regress. No signs of secondary infection or systemic involvement were observed. After clinical stabilization and reduction in lesion severity, the patient was shifted to the room(isolated). Further course in the hospital was uneventful, and she was discharged with dermatology follow-up.











Discussion

This case highlights the dangers associated with the use of unregulated medications from unqualified sources, a significant public health challenge in India [12]. Bullous drug eruptions, including Stevens-Johnson syndrome or toxic epidermal necrolysis (though not confirmed here), can be life-threatening [1,2]. The mortality associated with these conditions varies from approximately 10% for SJS to almost 50% for TEN [1,8].


Several factors contribute to poor prognosis in severe bullous drug eruptions, including larger extent of skin detachment, older age, and underlying comorbidity [1]. The SCORTEN (Score of Toxic Epidermal Necrolysis) is commonly used to determine prognosis, consisting of 7 parameters: age ≥40 years, heart rate ≥120/min, presence of cancer/hematologic malignancy, >10% body surface area involvement, raised blood urea nitrogen, serum bicarbonate <20 mmol/L, and serum glucose level >14 mmol/L [10,13].


The pathogenesis of bullous drug eruptions involves complex immunological mechanisms. Drug-specific T cells play a crucial role in the development of these reactions, with genetic factors such as HLA associations contributing to individual susceptibility [1,14]. The release of cytotoxic proteins like granulysin, perforin, and granzyme B leads to keratinocyte apoptosis and epidermal detachment [14].


Management of severe bullous drug eruptions requires a multidisciplinary approach. Immediate withdrawal of all suspected drugs is the key to management, as earlier withdrawal is associated with better prognosis [10,11]. Supportive measures including fluid-electrolyte balance, wound care, and prevention of secondary infections are essential [10,11]. The use of systemic corticosteroids remains controversial, but early short-course therapy may be beneficial in selected cases [10,11,15]. Other immunomodulatory treatments such as cyclosporine, intravenous immunoglobulin, and tumor necrosis factor-alpha inhibitors have shown variable results [10,11].


In India, case reports of bullous fixed drug eruptions have been documented with various medications. Agarwala et al. reported a case of bullous fixed drug eruption due to paracetamol from South India [9]. Similarly, Prathap et al. described a case of fixed drug eruption due to linezolid from Tamil Nadu [16]. A clinical study by Patel and Marfatia from Gujarat found that cotrimoxazole was the most common cause of fixed drug eruptions, followed by NSAIDs [6].


In developing countries like India, unregistered practitioners continue to pose a significant public health challenge [12]. These practitioners often prescribe medications without proper knowledge of their indications, contraindications, or adverse effects. This case underscores the need for stricter regulation against unlicensed practitioners and increased public awareness about the potential dangers of seeking healthcare from unqualified sources.


Conclusion

Patients presenting with widespread bullous lesions should be thoroughly evaluated for potential drug-induced etiologies. Early recognition, prompt discontinuation of the offending agent, and appropriate supportive care are crucial for favorable outcomes. This case emphasizes the importance of public awareness and stricter regulation against unlicensed practitioners to prevent such adverse events, particularly in the Indian context where self-medication and consultation with unregistered practitioners remain common practices.


References

1. Mockenhaupt M. Bullous drug reactions. Acta Derm Venereol. 2020 Feb 12;100(5):570. doi: 10.2340/00015555-3408.

2. Butler DF, James WD. Drug-induced bullous disorders. Medscape Reference. Updated Apr 3, 2023. Available from: https://emedicine.medscape.com/article/1062790-overview.

3. Patel TK, Thakkar SH, Sharma D. Cutaneous adverse drug reactions in Indian population: A systematic review. Indian Dermatol Online J. 2014;5(Suppl 2):S76-86. doi: 10.4103/2229-5178.146165.

4. Padmavathi S, Manimekalai K, Ambujam S. Causality, severity and preventability assessment of adverse cutaneous drug reaction: A prospective observational study in a tertiary care hospital. J Clin Diagn Res. 2013;7:2765-7. doi: 10.7860/JCDR/2013/7430.3753.

5. Breathnach SM, Phillips MA. Epidemiology of bullous drug eruptions. Clin Dermatol. 1993 Oct-Dec;11(4):441-447.

6. Patel RM, Marfatia YS. Clinical study of cutaneous drug eruptions in 200 patients. Indian J Dermatol Venereol Leprol. 2008;74:430. doi: 10.4103/0378-6323.42883.

7. Dyall-Smith D. Bullous drug eruptions. DermNet NZ. 2009. Available from: https://dermnetnz.org/topics/bullous-drug-eruptions.

8. Sekula P, Dunant A, Mockenhaupt M, et al. Comprehensive survival analysis of a cohort of patients with Stevens-Johnson syndrome and toxic epidermal necrolysis. J Invest Dermatol. 2013;133(5):1197-1204.

9. Agarwala MK, Mukhopadhyay S, Raja Sekhar M, Peter CVD. Bullous fixed drug eruption probably induced by paracetamol. Indian J Dermatol. 2016;61:121. doi: 10.4103/0019-5154.174098.

10. Kumar R, Das A, Das S. Management of Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis: Looking Beyond Guidelines! Indian J Dermatol. 2018 Mar-Apr;63(2):117-124. doi: 10.4103/ijd.IJD_583_17.

11. Creamer D, Walsh SA, Dziewulski P, et al. U.K. guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis in adults 2016. Br J Dermatol. 2016;174(6):1194-1227.

12. Rao KD, Shahrawat R, Bhatnagar A. Composition and distribution of the health workforce in India: estimates based on data from the National Sample Survey. WHO South East Asia J Public Health. 2016;5(2):133-140.

13. Bastuji-Garin S, Fouchard N, Bertocchi M, et al. SCORTEN: a severity-of-illness score for toxic epidermal necrolysis. J Invest Dermatol. 2000;115(2):149-153.

14. Chung WH, Wang CW, Dao RL. Severe cutaneous adverse drug reactions. J Dermatol. 2016;43(7):758-766.

15. Gupta LK, Martin AM, Agarwal N, et al. Guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis: An Indian perspective. Indian J Dermatol Venereol Leprol. 2016;82:603-25. doi: 10.4103/0378-6323.191134.

16. Prathap TA, Lokeshvaran D, Abinish DG, Kalaivani S, Aswin J. A rare case report on linezolid induced fixed drug eruption. Int J Res Dermatol. 2025;11(2):167-170. doi: 10.18203/issn.2455-4529.IntJResDermatol20250438.

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