Dexamethasone/methylprednisolone/prednisolone

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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 man in his 50s developed psychosis following treatment with off-label dexamethasone for COVID-19 and methylprednisolone and prednisolone for respiratory distress [not all routes and dosages stated].

The ex-smoker man, who had a history of type 2 diabetes mellitus, hypertension and non-alcoholic fatty liver disease, admitted to the hospital due to COVID-19 in November 2020. Prior to the admission, he was taking atorvastatin, gliclazide, enalapril, lansoprazole, metformin and linagliptin. Subsequently, he was admitted to the ICU due to decreased oxygen saturation and required ventilatory support. He started receiving remdesivir and off-label treatment with dexamethasone for Covid-19 as part of the Randomised Evaluation of Covid-19 Therapy (RECOVERY trial). One day later, tocilizumab was added to the therapy as off-label treatment. Antibiotic therapy with clarithromycin and amoxicillin was initiated and then escalated to piperacillin/tazobactam [Tazocin]. Thereafter, he was shifted to the general ward. His imaging study of the chest revealed fibrosis and organising pneumonia. Afterwards, he started receiving IV methylprednisolone for three days due to respiratory distress and then weaned down to oral prednisolone 20mg. Subsequently, he was discharged to home with a reducing regimen of steroid therapy. Post-discharge, he had to struggle to sleep and experienced several panic attacks. He was hearing voices and developed tactile hallucinations. He developed agitation and begun pacing around, whenever the voices would become overwhelming. He lost interest in the activities and was slapping his face and biting the fingers.

Thus, the man consulted with general practitioner and prescribed with sertraline. However, his symptoms progressed and became worse. Therefore, he presented to the emergency department and underwent psychiatry assessment that revealed agitation and emotional distress. He was unable to sit down and was hearing voices. Response to unseen stimuli was observed and he experienced both visual and auditory hallucinations. Subsequently, he was discharged on home treatment with risperidone and benzodiazepines. Sertraline was discontinued. But, he had continued worsening of the symptoms with increased agitation. He was harming himself by hitting the head against the walls and was lashing out. He was found floridly psychotic and responding to unspecified stimuli. Therefore, he again presented to the accident and emergency department, where he had persistent agitation and was banging the head. Hence, he was shifted to psychiatric ward for further treatment and he was found to have persistent restlessness, distress and difficulty to establish rapport with him. Response to external stimuli was observed; however, the symptoms were less severe in comparison with the symptoms presented at the accident and emergency department. He had improvement after antipsychotic treatment and his hallucinations resolved. However, he remained anxious. Few days later, he was able to sleep better and had less depressive symptoms. One week after the admission, he experienced one panic attack at night and was hitting his head on the wall and shouting. Thus, the dose of risperidone was increased and his anxiety improved. Within next two weeks, he had improvement in most of the psychotic symptoms. Eventually, he was discharged from the hospital with little anxiety and continued risperidone. His benzodiazepines were stopped. During the admission, he was diagnosed with psychosis [duration of treatments to reaction onset not stated]. After the discharge, follow-up treatment with early intervention services was scheduled. At the follow-up visit, his daughter reported no concerns for his behavior. But, he experienced trouble in sleeping on one occasion and had urge to scratch himself rarely. He was continued on his antipsychotic therapy.