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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 67-year-old man developed symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) following treatment with remdesivir on a compassionate-use basis for coronavirus disease 2019 (COVID-19). Additionally, sufentanil, propofol, norepinephrine, pantoprazole, polyethylene-glycol, enoxaparin-sodium and metoclopramide contributed in the development of SDRIFE [not all indications and durations of treatments to reactions onsets stated].
The man, who was suffering from COVID-19, was transferred from Northern Italy to the Central Hospital of the German Armed Forces, Germany, on 29 March 2020, as a part of an international medical evacuation operation. He had been mechanically ventilated since 19 March 2020 due to acute respiratory distress syndrome (ARDS). In Italy, he had been treated with IV remdesivir on a compassionate-use basis for four consecutive days (26 March 2020 to 29 March 2020). In Italy, he had been treated with IV remdesivir 200 mg/day on 26 March 2020 and 100 mg/day from 27 March 2020 to 29 March 2020. It was found that he had been receiving IV norepinephrine 50−300 µg/h, IV pantoprazole 40 mg/day, polyethylene-glycol [macrogol] 13 g/day via feeding tube, SC enoxaparin-sodium [enoxaparin] 40 mg/day and IV metoclopramide 10 mg/day. It was also found that from 19 March 2020 he had been receiving IV sufentanil 50−100 µg/h and IV propofol 60−240 mg/h. On 30 March 2020, he developed an erythematous macular exanthema on his trunk with pronounced involvement of both axillae, the inguinal and submental region. Notably, serous bullae with a diameter of up to 6cm emerged in his axillae. He was physically examined by a senior dermatologist who established the diagnosis SDRIFE. To evaluate the likelihood of each drug with regard to SDRIFE, the Naranjo ADR Probability Scale was used. The Naranjo score for remdesivir was + 3. The Naranjo score for sufentanil, propofol, norepinephrine, pantoprazole, polyethylene-glycol, metoclopramide and enoxaparin-sodium was + 1. Based on the Naranjo ADR Probability Scale score, remdesivir was considered as the primary offending agent. Additionally, sufentanil, propofol, norepinephrine, pantoprazole, polyethylene-glycol, enoxaparin-sodium and metoclopramide were considered to have played a role in the development of SDRIFE.
The man's therapy with propofol, metoclopramide and norepinephrine was discontinued on 4 April 2020, 17 April 2020 and 21 April 2020, respectively. The administration of sufentanil, pantoprazole, polyethylene-glycol and enoxaparin-sodium were continued until transfer of the patient to a rehabilitation clinic on 23 April 2020. The SDRIFE resolved spontaneously over the following weeks without further intervention.
Heck J, et al. Remdesivir-induced symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)? A case report with review of the literature. European Journal of Clinical Pharmacology 77: 141-144, No. 1, Jan 2021. Available from: URL: http://doi.org/10.1007/s00228-020-02955-4