Pfizer COVID-19-related drug use and safety surveillance

Abstract

Pfizer COVID-19-related drug use and safety surveillance Pfizer has reported COVID-19-related drug utilisation and safety data which are expected to inform the ongoing care of patients with COVID-19, in a pharmacovigilance surveillance study published in Drug Safety.This retrospective study reviewed adverse event (AE) data from the Pfizer global safety database on Pfizer products used worldwide in a total of 1508 patients with COVID-19 infections between October 2019 and June 2020.Cases with COVID-19 most frequently used immunosuppressants or immunomodulators, followed by anticoagulants, antithrombics and corticosteroids. Off-label drug use for the management of COVID-19-related conditions included antibacterials, antimalarials, antivirals/antiretrovirals, immunosuppressants/immunomodulators, corticosteroids, anticoagulants and immunoglobulin/interferons. The most frequently reported drugs were azithromycin, chloroquine or hydroxychloroquine, fixed-combination or single agent lopinavir and ritonavir, ceftriaxone and tofacitinib.The most frequently reported AEs associated with azithromycin alone or in combination with chloroquine or hydroxychloroquine were QT-interval prolongation, drug interactions, diarrhoea, and chronic or acute hepatitis. QTinterval prolongation or torsades de pointes were reported in 19% of azithromycin-treated cases and resulted in death in seven cases. The most frequently reported AEs in patients receiving lopinavir/ritonavir were diarrhoea, elevated transaminase levels, QT-interval prolongation, drug interactions, hyperbilirubinaemia and hypertriglyceridaemia. Hepatitis was the most frequently reported AE in patients receiving ceftriaxone. One patient who received tofacitinib with concurrent immunosuppressants developed acute pancreatitis."In further recognizing the need for maintaining a global safety database of drugs used for the management of COVID-19, a consortium formed by regulatory authorities and national health agencies, as well as a framework for systemic risk-benefit assessment tools, would be beneficial in centralizing the accumulating pharmacovigilance-related information pertaining to COVID-19," commented the authors.