(P-171) Adverse Events Associated with Remdesivir in covid-19 Patients: Evaluation of Spontaneous Reports Submitted to US FDA Adverse Event Reporting System (FAERS)

Location: Poster Gallery-Pharmacovigilance

Presenting Author(s)

Jahnavi Yalamanchili

Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences

Co-Author(s)

RN

Reddy Neha

Pharm-D, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, India, India
VS

Viswam Subeesh

Assistant Professor, Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, India, India
NG

Nair Gouri

Assistant Professor, Department of Pharmacology, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, India, India
FM

Faizan Mazhar

A Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, “Luigi Sacco” University Hospital, Università Di Milano, Milan, Italy, Italy

Background: Covid-19 is an ongoing pandemic that caused widespread health crisis. In May 2020, FDA approved Remdesivir, an investigational broad-spectrum antiviral, for emergency use in hospitalized severe covid-19 adult and paediatric patients.

Objectives: This study aims to explore potential adverse events associated with remdesivir in covid-19 patients, by evaluating FDA Adverse Event Reporting System (FAERS) reports.

Methods: The FAERS database was searched from January 2020 to June 2020, to retrieve all reports on covid-19. The reports corresponding to remdesivir as primary or secondary suspect was sorted and outcomes were classified using descriptive statistics.

Results: Out of 3695 covid-19 reports, remdesivir was primary suspect and secondary suspect in 1127 (30.50%) and 176 (4.76%) respectively. Out of 1140 unique reports, mean age was 60.36 years with majority above 60 years (n=642; 56.32%) and missing data in 14 (1.23%). Males, females and missing gender data comprised of 692 (60.70%), 440 (38.60%) and 8 (0.70%) reports respectively. The major adverse events were acute kidney injury (n=166; 5.75%), alanine aminotransferase increased (n=161; 5.58%), aspartate aminotransferase increased (n=124; 4.30%), blood creatinine increased (n=124; 4.30%), liver function test increased (n=82; 2.84%), death (n=79; 2.74%), hypotension (n=74; 2.56%), respiratory failure (n=54; 1.87%), glomerular filtration rate decreased (n=50; 1.73%), renal impairment (n=50; 1.73%) and others (n=1923; 66.61%). The outcomes associated were death (n=265; 23.83%), hospitalization (n=141; 12.68%), life-threatening (n=65; 5.85%) and other serious event (n=641; 57.64%).

Conclusions: In conclusion, remdesivir use may affect renal and hepatic function, and cause hypotension in covid-19 patients. Thus, awareness regarding these risks is essential to mitigate complications.