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- Indian J Pharmacol
- v.56(1); Jan-Feb 2024
- PMC11001176
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Indian J Pharmacol. 2024 Jan-Feb; 56(1): 58–60.
Published online 2024 Mar 8. doi:10.4103/ijp.ijp_485_23
PMCID: PMC11001176
PMID: 38454591
Asfiya Samar, GN Sahana, P Deepak, Jayashree V Nagaral, and M Saranyaa
Author information Article notes Copyright and License information PMC Disclaimer
Abstract
Stevens–Johnson syndrome is a severe adverse drug reaction affecting the skin and mucous membrane. The causes include Sulfonamides, Anticonvulsants, etc. A patient developed ulcerations in the lips and oral cavity with difficulty in swallowing and rashes over the back, abdomen, and genitalia following administration of injection ceftriaxone 1 g intravenous (IV) b.i.d, injection pantoprazole 40 mg IV b.i.d, tablet aceclofenac + paracetamol 325 mg b.i.d, tablet cetirizine 10 mg b.i.d, chlorhexidine mouth wash, and injection metronidazole 500 mg IV t.i.d for the treatment of traumatic facial injury after 4 days of treatment. Injection ceftriaxone and tablet aceclofenac + paracetamol were suspected as the cause of this reaction. The two drugs were stopped. The patient was treated with corticosteroids, other antimicrobials, and oral topical anesthetics. Health-care providers should be careful about the possible adverse drug reactions even to commonly used drugs.
Keywords: Aceclofenac, ceftriaxone, paracetamol, Stevens–Johnson syndrome
Introduction
Stevens–Johnson syndrome (SJS) is a severe adverse drug reaction affecting the skin and mucous membrane.[1]
The incidence of SJS is 0.05–2 persons per 1 million population per year.[2]
It presents as skin and mucous membrane manifestations in the form of blisters, ulcerations, and crusting, associated with pain.[3]
SJS and toxic epidermal necrolysis are immune-mediated reactions that can be caused by a variety of etiological causes, including medications, infections, cancer, and radiation therapy. Drugs are the most often involved causative agent.[4]
These include medications such as sulfonamides, anticonvulsants (phenytoin, phenobarbitone, and carbamazepine), nonsteroidal anti-inflammatory drugs (NSAIDs), and allopurinol.
Case Report
A 50-year-old male patient was admitted to the department of otorhinolaryngology of a tertiary health-care center for complaints of self-fall from a bike following which he developed injuries over his face, forehead, cheek, right forearm, right hand, and right leg. There was no history of vomiting or loss of consciousness.
Past history
The patient is a case of type 2 diabetes mellitus for 10 years and is on treatment with insulin Mixtard 15 U in the morning and tablet pioglitazone 15 mg, tablet metformin 500 mg, and glimepiride 2 mg once a day.
The patient had two episodes of rashes, itching, and allergy in the past to some unknown drug that he had taken for control of fever under the prescription of a doctor, and again for the second time when he was admitted for fever in the hospital, the patient received an injection and developed rashes similar to the current symptoms. The patient does not know the exact name of the drugs and does not contain documents for the same.
Family history was not significant.
Personal history revealed, patient had mixed diet, good appetite, sound sleep. patient was a chronic smoker and alcoholic.
General physical examination – patient is conscious, cooperative, and well oriented to time, place, and person.
There was no Pallor, icterus, clubbing, cyanosis, lymphadenopathy and edema.
Vitals were measured and values noted are as below
On examination, a sutured wound on the left frontal region measuring 2 cm × 4 cm. Left-sided periorbital edema was present. The left cheek had swelling with associated tenderness.
CT scan revealed no significant intracranial abnormality with fractures of the left zygomatic bone.
The patient was given the following medications to treat traumatic facial injury: injection ceftriaxone 1 g intravenous (IV) b.i.d, injection pantoprazole 40 mg IV b.i.d, tablet aceclofenac + paracetamol 325 mg b.i.d, tablet cetirizine 10 mg b.i.d, chlorhexidine mouth wash, and injection metronidazole 500 mg IV t.i.d. He was given the above medications for 4 days. On the 5th day, the patient complained of painful lesions in the oral cavity associated with difficulty in swallowing, and rashes involving the back, right abdomen, and genitals, associated with pain. On examination, ulcerations were present over the erythematous base with peeling of skin present over the left upper back and right lumbar region approximately measuring 10 cm × 5 cm. There was erythematous crusting of the lips, ulcerations in the buccal mucosa, inability to open the mouth, and oropharyngeal candidiasis present [Figure 1]. In the genitals, erosions were present over the scrotum with mucopurulent discharge [Figure 2]. The glans penis was not involved. Vitals: pulse – 98 bpm, BP – 110/70 mmHg, respiratory rate – 18 cpm, and temperature – febrile with a body temperature of 98°F.
Figure 1
Erythematous crusting of the lips, ulcerations in the buccal mucosa
Figure 2
Erosions present over the scrotum – mucopurulent discharge. Glans penis – not involved
Investigations revealed the following: white blood cells – 6 × 103/µL, neutrophils – 62.4%, lymphocytes – 33.2%, eosinophils – 2.2%, hemoglobin – 15.6 g/dl, platelets – 280 × 103/µL, aspartate aminotransferase – 16 U/L, alanine aminotransferase – 20 U/L, creatinine – 0.9 mg/dl, and glucose – 385 mg/dl.
Diagnosis of SJS was made. Injection ceftriaxone and tablet aceclofenac + paracetamol 325 mg were stopped. The patient was treated with injection dexamethasone 4 mg IV o.d for 5 days, and tablet prednisolone 5 mg 1-0-0 for the next 5 days was prescribed for anti-inflammatory and immunomodulatory action. Tablet fluconazole 50 mg h.s for 14 days was prescribed for treating oropharyngeal candidiasis, clotrimazole oral paint t.i.d for 2 weeks for applying to oral candidiasis lesions, triamcinolone acetonide gel h.s for 1 month for application to erosions over the lip and buccal mucosa for its anti-inflammatory effect, and benzocaine gel t.i.d for local application to oral cavity lesions for a period of 1 month for analgesic effect was given. Injection tazobactam 4.5 mg IV b.i.d for treating infection, injection regular insulin 14-14-12U for controlling high blood sugars was prescribed.
Prognosis
After 5 days of treatment for SJS in the hospital, the patient had mild improvement and symptoms started subsiding, and was discharged. On discharge, the patient was asked to continue the above medications as follows: tablet prednisolone 5 mg 1-0-0 for 5 days, tablet fluconazole 50 mg hs for 5 days, triamcinolone acetonide gel for the next 20 days to oral cavity lesions, and benzocaine gel t.i.d for the next 20 days. After 2 weeks, the patient was followed up and there was a significant improvement in symptoms, and lesions resolved, however, pigmentation persisted. Oral ulcers had healed. No major complaints remained again after 2 weeks of the first follow-up. The patient did not have any complications.
Discussion
Diagnostic criteria for SJS are epithelial detachment of < 10% of body surface area and extensive erythematous or purpuric macules of flat atypical targets. SJS and toxic epidermal necrolysis (TEN) are characterized by severe cutaneous disorder, acute skin blisters, and mucous membrane erosions. Body surface area involvement is <10% in SJS and >30% for TEN.[4]
Causes for SJS include antimicrobials, NSAIDs, and anticonvulsants. Nevirapine, paracetamol, cotrimoxazole, phenytoin, and zidovudine were found to be the most commonly associated drugs.[5]
Conclusion
This case report concludes that SJS was probably caused by tablet aceclofenac + paracetamol and injection ceftriaxone. This case study concludes a probable association between the above two drugs and the onset of SJS as per the WHO scale and Naranjo’s scale.
Health-care providers should be careful about the possible adverse drug reactions even to commonly used drugs.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given his consent for his images and other clinical information to be reported in the journal. The patient understands that his name and initials will not be published, and due efforts will be made to conceal his identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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5. Nirmala SV, Dadeepya R, Lalitha V, Sivakumar N, Sandeep C. A case of Stevens-Johnson syndrome. El Mednifico J. 2014;2:299–300. [Google Scholar]
Articles from Indian Journal of Pharmacology are provided here courtesy of Wolters Kluwer -- Medknow Publications