ABSTRACT
Objective: To describe the suspected adverse reactions (SADRs) associated with drugs used to treat COVID-19. Material and/or methods: This is an observational, retrospective study of SADRs identified by the Bellvitge Hospital Pharmacovigilance Program (PFVHUB). All patients admitted and treated with specific drugs for COVID-19, from 10 to 28 March 2020 were included. Data were collected regarding patients' characteristics, medications and suspected ADRs. Information was obtained from clinical records. Results: A total of 760 patients were included, out of which 95 (12.5%) presented 105 SADRs, being 176 drugs implicated. The mean age was 65 years old and 470 (62%) were men. From a total of 677 (89%) patients with pneumonia, 251 (37%) were considered severe. There were 161 (21.2%) deaths. The medication administered was: hydroxychloroquine (737 [97%]), ritonavir/lopinavir combination (542 [71%]), beta-Interferon (196 [25.8%]), tocilizumab (114 [15%]) and remdesivir (9 [1.2%]). The most frequent SADRs were: diarrhoea (55 [52.4%]), QT lengthening (18 [17%]), hepatitis (7 [6.7%]), nausea (5 [4.7%]) and acute renal failure (3 [2.8%]). Regarding the 95 patients with suspected ADRs, median age was 61.5 years and 54 (57.4%) were men;89 (94%) had pneumonia;and 24 (27%) cases were severe. There was no case of SADR-related death. In 65 cases (63%) the drug was withdrawn. Recovery was achieved in 97 (92.4%) cases, with a median duration until recovery of 4 days (IQR 2-7). According to the causality algorithm of the Spanish Pharmacovigilance System, causality was deemed probable for 139 (79%) of the drugs involved. Conclusions: SADRs correspond to the known risk profile of the drugs used. Although the majority of cases recovered in approximately 4 days, more than half of the cases required the medication to be withdrawn.
ABSTRACT
Objective: To describe the COVID-19 vaccine-related suspected adverse reactions (ADRs) reported to the Catalan Pharmacovigilance Center (CFVC) by the Bellvitge Hospital Pharmacovigilance Program (PFVHUB). Material and/or methods: This is an observational, retrospective study of suspected ADRs not stated in the Summary of Product Characteristics at the time of authorization and reported between January and October 2021. Suspected ADRs, both in healthcare professionals or their patients, were identified through spontaneous notifications made by these professionals themselves. Information was collected on patients' characteristics, adverse events, type of vaccine administered, severity, outcome and degree of accountability. Results: In total, 920 suspected ADRs were reported (894 in healthcare professionals and 26 in patients). Of these, 42 suspected ADRs among professionals were reported to the CFVC and 24 among patients. The mean age was 46.6 years, 70% were in women and 7 cases had COVID-19 previously. In 56% of the cases, the suspected ADR occurred after the first dose and in 5 cases it happened once again after the second dose. In 55 (83%) cases, the administered vaccine was Comirnaty®. The most frequent suspected ADRs were herpes zoster and simplex, oral fungal infection, paresthesia, pruritic rash, urticaria, myocarditis/pericarditis, thrombosis, cytolytic hepatitis, facial paralysis, flu-like syndrome, vertigo and thoracoepigastric vein phlebitis. In 88% of the cases, the median duration of the ADR until recovery was of 7 days (IQR 2-15). According to the causality algorithm of the Spanish Pharmacovigilance System, causality was probable or possible in 89% of the cases. Conclusions: Suspected ADRs identified by means of the PFVHUB have contributed to improve the knowledge regarding the toxicity profile of COVID-19 vaccines.