. 2023 Mar 7. Online ahead of print. doi: 10.1016/j.therap.2023.03.001

Table 4.

Summary of reports of deaths reported with nirmatrelvir/ritonavir (Paxlovid®) recorded in the French pharmacovigilance database over the period from 01/20/2022 to 12/03/2022.

Sex (F/M)/age group (years)	Suspect drug	Reported ADRs	Reported cause of death	DDI?	Comment
F/70–80	Comirnaty®	Vaccination failure	ARDS --> undetermined etiological shock on COVID19 variant Omicron BA.2	No evidence of cessation of lercanidipine (risk of hypotension due to elevated plasma concentrations)	–
F/70–80	Paxlovid®	Drug inefficiency			–
F/70–80	Paxlovid®	Cardiorespiratory arrest	Unknown	No information concerning the cessation or continuation of certain drugs of the usual treatment (in particular lercanidipine and atorvastatin)	93% oxygen saturation prior to Paxlovid® + multiple CV risk factors (hypertension, type 2 diabetes, obesity, high cholesterol, sleep apnea syndrome, chronic kidney failure, etc.)
F/80–90	Paxlovid®	Pseudomonas pneumonia	Multi-organ failure due to COVID-19 infection and Pseudomonas aeriginosa superinfection	Undocumented	–
F/80–90	Paxlovid®	Drug inefficiency		Undocumented	–
F/80–90	Paxlovid®	Ischemic stroke at D6 from initiation of Paxlovid®	Ischemic stroke	Undocumented	Lack of SARS-CoV-2 vaccination
M/80–90	Paxlovid®	Sudden death at D1 of Paxlovid® and D2 of nadolol	Sudden multifactor death	No	Context of liver decompensation on alcoholic cirrhosis, myeloproliferative syndrome being explored and multiple CV risk factors (hypertension, type 2 diabetes, CAAF, etc.)
M/80–90	Nadolol	Sudden death at D1 of Paxlovid® and D2 of nadolol	Sudden multifactor death	No
M/90–100	Paxlovid®	Melena	Deglobulization + palliative management	No	Context of prostatic abscess treated with antibiotic therapy
M/90–100	Enoxaparine	Melena	Deglobulization + palliative management	No
M/90–100	Paxlovid®	Ischemic stroke at D17 from initiation of Paxlovid®	Ischemic stroke	Undocumented	–
F/80–90	Paxlovid®	Drug inefficiency	Unknown	No	At D1: apixaban relai for enoxaparin with respect to DDI risk
F/80–90	Enoxaparine	Drug inefficiency	Unknown	No
F/90–100	Paxlovid®	Complicated abdominal hematoma from secondary hemorrhagic shock	Multivisceral failure following shock	No	At D1: rivaroxaban relai for enoxaparin with respect to DDI risk
F/90–100	Enoxaparine		Multivisceral failure following shock	No
F/80–90	Paxlovid®	Cardiogenic shock on myocardial ischemia	COVID-19 nosocomial infection complicated from myocardial infarction with cardio-respiratory failure	No	Difficult home support given severe cognitive impairment

ADR: adverse drug reaction; ARDS: acute respiratory distress syndrome; CAAF: complete arrhythmia by atrial fibrillation; COVID-19: coronavirus disease 2019; CV: cardiovascular; D: day; DDI: drug-drug interaction; F: female; M: male; N: no; SARS-CoV2: severe acute respiratory syndrome coronavirus 2; Y: yes.