Cefditoren

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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 49-year-old woman developed acute generalised exanthematous pustulosis (AGEP) during off label treatment with cefditoren for severe respiratory failure related to severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2).

The woman with morbid obesity was admitted to the ICU due to severe respiratory failure. Following testing, she was found positive for SARS-CoV-2 and required invasive ventilatory support in the ICU for 24 days. During this period, she received off label treatment with tocilizumab single dose 600mg, interferon-β 250mg every 24 hours, hydroxychloroquine 200mg every 12 hours, azithromycin 500mg every 24 hours, ceftriaxone 2g every 12 hours, lopinavir/ritonavir 800/200 every 24 hours and methylprednisolone 40mg every 12 hours. After successful extubation, she was shifted to the pneumology ward and remained asymptomatic. All her medications were discontinued, except methylprednisolone, which was tapered to 16mg daily. After 7 days, her respiratory symptoms worsened. Therefore, she was started on off label empiric treatment with cefditoren 400mg every 12 hours [route not stated]. The following day, she developed fever of 38.4°C. Blood tests showed neutrophilia (7.75 × 10³ /µL) and CRP of 59 mg/L. A skin rash was also noted. Physical examination revealed a confluent reddish macular rash on the trunk, which involved the neck, face, arms, neck folds and axillary. Small widespread pustules developed over the macules. Based on these findings a clinical diagnosis of AGEP related to cefditoren was suspected [duration of treatment to reaction onset not stated].

The woman stopped receiving cefditoren; methylprednisolone dose was increased. Subsequently, the skin lesions improved along with her general condition. Histological analysis showed papillary oedema, few eosinophils within superficial dermis and subcorneal pustules with abundant inflammatory infiltrate. Hence, a diagnosis of AGEP was confirmed.