Risk Signals for Neonatal Use of Poractant Alfa Based on FAERS Database Mining and Analysis

OBJECTIVE  To mine and analyse adverse event(AE) signals for neonatal use of poractant alfa based on the FDA Adverse Event Reporting System(FAERS) database.

METHODS  AE reports related to poractant alfa as the primary suspected drug collected from the FAERS database from Q1 2004 to Q1 2024 using the OpenVigil 2.1-MedDRA data platform. The proportional reporting ratio(PRR) method and reporting odds ratio(ROR) method were used for data mining. The mined risk signals were classified and described using the preferred terminology(PT) and preferred system organ classification(SOC) of the "Adverse Drug Reaction Terminology Set" in the International Dictionary of Medical Terminology(version 26.1).

RESULTS  A total of 622 adverse drug event(ADE) reports involving 223 PT signals were collected for neonatal use of poractant alfa. The countries with a higher number of reported cases were the United States, Poland, and China. A total of 43 ADE positive signals were obtained after calculation and screening for exclusion by PRR and ROR methods. Among them, the ADE signals with signal frequency in the top 3 were neonatal hypoxia, neonatal pulmonary haemorrhage, and neonatal bradycardia. The top 3 PTs in terms of ADE signal intensity (PRR method) were neonatal hypoxia, end-tidal CO₂ decreased and cardio-respiratory arrest neonatal. In comparison with the poractant alfa specification, 17 ADE signals were not yet included in the specification, such as ill-defined disorder, death neonatal, and infantile apnoea; there were 10 new SOCs, including infections and infestations, general disorders and administration site conditions, surgical and medical procedures, skin and subcutaneous tissue disorders, injury, poisoning and procedural complications, nervous system disorders, pregnancy, puerperium and perinatal conditions, gastrointestinal disorders, vascular disorders.

CONCLUSION Based on the mining of AE signals in the FAERS database, it is shown that when using poractant alfa in clinical practice for neonatal, in addition to paying attention to adverse reactions recorded in the instructions, attention should also be paid to ill-defined disorder, death neonatal , infantile apnoea, end-tidal CO₂ decreased and cardio-respiratory arrest neonatal and other adverse events to ensure the safety of neonatal medication.