(P-079) Safety of Propofol Use in Children and Adolescents: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS)

Location: Poster Gallery-Pharmacovigilance

Presenting Author(s)

HL

Hailong Li

Department of Pharmacy, West China Second University Hospital, Sichuan University, Sichuan, China (People's Republic)

Co-Author(s)

ZB

Zhenyan Bo

Department of Pharmacy, West China Second University Hospital, Sichuan University, Sichuan, China (People's Republic)
LZ

Lingli Zhang

1.Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, 610041, China 2.Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, 610041, China 3.Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, 610041, China, Sichuan, China (People's Republic)

Background: Propofol is an intravenous agent used commonly for induction and maintenance of anesthesia, procedural and critical care sedation in children. But some concerns remain regarding respiratory and/or cardiac complications in patients receiving propofol.

Objectives: To assess the overall safety of propofol in pediatric population using FDA Adverse Event Reporting System (FAERS) Database.

Methods: We conducted case by non-case disproportionality analysis to detect the propofol related adverse events in the population <18 years old. Using FAERS database, we identified the reports associated with propofol from January 2004 to December 2020. Proportional reporting ratio (PRR) was calculated to assess the association between drug and suspected adverse events. A positive signal was defined as PRR at least two, chi-squared of at least four, and three or more cases. Subgroup analyses were performed in the following age categories: 0–1 month, 0–2, 3–11 and 12–17 years.

Results: Overall, 1,043 (0.34%) out of 310,574 records concerned propofol in pediatric population. Most of the reported propofol concerned children aged 12–17 years. We detected 198 positive signals out of 858 kinds of adverse events. In order of decreasing frequency of events, the top 5 adverse events were as follows: ‘cardiac arrest’ (n = 89, PRR=11.4, χ2 = 807), ‘metabolic acidosis’ (n = 69, PRR=13.1, χ2 = 731), ‘rhabdomyolysis’ (n = 69, PRR=24.2, χ2 = 1402), ‘bradycardia’ (n = 64, PRR=10.4, χ2 = 517), ‘hypotension’ (n = 62, PRR=4.8, χ2 = 182). Expected signals were found for ‘agitation’ (n = 41, PRR=3.0, χ2 = 53), tachycardia (n = 60, PRR= 5.0, χ2 = 186), respiratory arrest (n = 20, PRR=5.3, χ2 = 64), laryngospasm (n = 28, PRR=66.5, χ2 = 1423), apnoea (n = 18, PRR=5.1, χ2 = 54), and etc.

Conclusions: Further confirmation from a large case-control/cohort study is needed to validate these adverse effects.