Loxoprofen

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 52-year-old woman developed drug eruption during non-steroidal anti-inflammatory therapy with loxoprofen [route and dosage not stated].

The woman presented to the clinic with itchy erythematous lesions on her limbs and erosions on her lips and buccal mucosa. She had been treated with loxoprofen [loxoprofen sodium hydrate] and cefcapene pivoxil [cefcapene pivoxil hydrochloride hydrate] at a dental clinic 3 days previously (day -3). After 2 days (day -1), she developed erythematous lesions and erosions on her lips. She was diagnosed with drug eruption (day 0). Pathologic analysis of a skin biopsy of an indurated erythematous lesion on her leg demonstrated slight liquefaction with perivascular and periadnexal mixed cell infiltrations from the papillary dermis to the deep subcutaneous tissue. Deep lymphocytic infiltrations were not typical for drug eruptions. Lymphocyte stimulation index of loxoprofen and cefcapene pivoxil were found to be 300% and 151%, respectively.

Subsequenly, the woman was treated with prednisolone. On Day 2, she was noted to have well-demarcated infiltrated erythema on her trunk. Eventually, the erosions of her lower lips and buccal mucosa improved. Then, dose of the prednisolone was reduced. Five days following the dose reduction of prednisolone (Day 7), she returned to the clinic with cough, high fever, chills, shortness of breath and fatigue. After investigations, she was diagnosed with pneumonia and admitted to an isolation ward with suspicion of COVID-19. On admission (day 7), the erythematous lesions worsened precipitously. Thus, prednisolone was stopped, and she received ampicillin/sulbactam and clarithromycin. On day 8, new macular papules and erythematous lesions were observed on her face and trunk with some petechiae. Pathologic analysis of a biopsy specimen of an indurated erythematous skin lesion on her abdomen showed interface changes with liquefaction and perivascular mixed cell infiltrations, including histiocytes and neutrophils in the papillary dermis. Subsequently, ampicillin/sulbactam was switched to levofloxacin. On day 10, the erythematous lesions peaked and gradually pigmented. On day 1 of admission, PCR analysis for COVID- 19 was negative. On day 3 of admission, a repeat PCR for COVID-19 was positive, and she was diagnosed with COVID-19. Then, she was transferred to the ICU at another hospital. Later, it was associated with was confirmed that the drug eruption loxoprofen. Association between COVID-19 and drug eruption was also suspected.