Comparative Study of Adverse Drug Reactions Associated with Filgrastim and Pegfilgrastim Using the EudraVigilance Database

Abstract

The primary prophylaxis with filgrastim (FIL) and pegfilgrastim (PEG-F) is recommended to decrease the severity of chemotherapy-induced neutropenia (CIN). The commonly reported adverse drug reactions (ADRs) with FIL and PEG-F is bone pain. ADRs pertaining to FIL and PEG-F were extracted from the European EudraVigilance (EV) database. The Individual Case Safety Reports (ICSRs) obtained from EV database that reported FIL and PEG-F as the suspected drug were analyzed. Registered ADRs (from the groups “General disorders and administration site conditions”, “Blood and lymphatic system disorders”, “Musculoskeletal and connective tissue disorders” and “Investigations”) for FIL and PEG-F were collected from EV database from 2007 to 5 June 2021. The reporting odds ratio (ROR) was used to calculate ICSRs with most common ADRs related to FIL and PEG-F. A total of 17,403 ICSRs described the incidence of most common ADRs of FIL and PEG-F. The commonly reported ADRs for both drugs were pyrexia, bone pain, back pain, neutropenia and febrile neutropenia. The odds ratio of ICSRs belonging to the System Organ Class (SOC) “Investigations” (ROR 1.01 (CI 0.93–1.10)) revealed no significant difference in FIL and PEG-F. However, for the SOCs (General disorders and administration site conditions” and “Musculoskeletal and connective tissue disorders” ((ROR 1.14 (CI 1.06–1.21); ROR 1.21 (CI 1.18–1.32), respectively), an increased reporting probability with PEG-F was found. The authors reported a lower reporting probability for the SOC “Blood and lymphatic system disorders” for FIL versus PEG-F (ROR 0.75 (CI 0.70–0.80)). Our results have demonstrated that the occurrence of bone pain was similar with FIL and PEG-F. For the incidence of pyrexia and back pain, PEG-F was associated with a higher reporting probability as compared to FIL. However, the incidence of neutropenia and febrile neutropenia was higher in FIL compared to PEG-F. Further evaluation of data from real life is needed.

Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study

“…The reason behind the distortion represented in the geographical origin of cases reported to the EV can be linked to the phenomenon that falsified medicine case reporting is more common in non-EEA countries and that there is an obligation to report all serious ADR, while in EEA countries not just the reporting but the drug supply chain regulation is tightly controlled. Although we do not know the exact explanation, what can be seen is that in the case of other research studies not related to falsified medicine ADRs, we have also found the dominance of non-EEA reports (Ferreira et al, 2022;Rastogi et al, 2022).…”

Comparative Analysis of Adverse Events Linked to PEG-rhG-CSF and rhG-CSF in Real-World Settings: Disproportionate Examination of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database

“…The analysis elucidated a noteworthy discrepancy in the onset times of AEs between PEG-rhG-CSF and rhG-CSF, with a particular focus on bone pain. The These findings accentuated the necessity of diligent patient follow-up, particularly considering the possibility of patients being discharged from the hospital prior to the onset of these delayed Aes [16] . In the future, the incidence of FN holds promise for reduction through the application of advanced drug development technologies and innovations.…”

An observational, prospective, open label, multicenter study to evaluate the safety and effectiveness of pegfilgrastim as secondary prophylaxis to decrease the incidence of febrile neutropenia in Korean female patients with breast cancer

“…In this observational study, the bone pain incidence rate related to pegfilgrastim was similar to the RCT results of 27.3–38.8%. Meanwhile, when reviewing the safety data of pegfilgrastim, the overall incidence rate of ADRs was 41.3%, of which bone pain was 6.9% from the European Eudra Vigilance database [ 26 ]. There were differences in race, the range of age, and the amount of the data between two databases.…”

“…Ten AEs of leukocytosis which was included in warning and precautions in label of pegfilgrastim were reported in our study [ 27 ]. There was no unusual AE in comparison with the European Eudra Vigilance database [ 26 ].…”