Signal for remdesivir-associated pancreatitis

Abstract

Treatment with remdesivir, an antiviral which has been approved in several countries for use in hospitalised COVID-19 patients, appears to be associated with pancreatitis, according to a signal published in the WHO Pharmaceutical Newsletter. A search of individual case safety reports (ICSRs) reported to VigiBase, the WHO global pharmacovigilance database, identified 12 unique ICSRs with remdesivir and the terms pancreatitis (n=6), acute pancreatitis (4) or oedematous pancreatitis (2), from five countries, as of 8 December 2020. One addition ICSR with the term amylase increased was included in this case series. Remdesivir was the only suspected drug in nine cases. The time to onset of pancreatitis was 1–9 (median 4) days. Currently, the summary of product characteristics for remdesivir does not mention pancreatic adverse events. The temporality and the positive dechallenge in several of the cases, together with biological plausibility, an analogy with other antiviral drugs, and the uncertainties in relation to COVID-19, support our claim that the hypothesis of a causal relationship between remdesivir treatment and pancreatic toxicity needs to be further monitored, said the author. Although not a strong signal, there is reason to further monitor the hypothesis, she said.