(P-363) Assessing the Post Marketing Experience of Clopidogrel and Major Cardiovascular Events After PCI in Saudi Arabia Using the Saudi Food and Drug Authority (SFDA) Spontaneous Reporting System

Location: Poster Gallery-Pharmacovigilance

Presenting Author(s)

RA

Rayan Ibrahim Alolayet

County Government of Laikipia
Riyadh, Al Riyadh, Saudi Arabia

Co-Author(s)

AA

Abdulrahman Alnuaim

Saudi Food and Drug Authority (SFDA), Saudi Arabia
MA

Muhanad AlHarbi

Head of Data Capture
The Saudi Food and Drug Authority, Saudi Arabia
MA

Mobarak S. Al-Shahrani

Director of the National Pharmacovigilance Center (NPC)
The Saudi Food and Drug Authority, Ar Riyad, Saudi Arabia

Background: Clopidogrel is a prodrug that undergoes hepatic biotransformation to generate active metabolites. It is standard of care to prescribe asprin and P2Y12 Inhibitor as Dual Antiplatelet Therapy (DAPT) to patient who underwent percutaneous coronary interventions (PCI). Local studies addressing Genetic Variability are scarce

Objectives: To evaluate the seriousness and relatedness of Clopidogrel major cardiovascular events in Saudi Arabia using the Saudi Food and Drug Authority’s (SFDA) spontaneous reporting system

Methods:

Design: cross-sectional study measuring spontaneous reports of Clopidogrel and major cardiovascular events after PCI received by the SFDA from January 2018 to January 2021. World Health Organization (WHO) causality assessment is incorporated into the report and will be used to assess the causality
Setting: The SFDA manages the Vigilance reporting System, which receives spontaneous reports from healthcare providers, Marketing Authorization Holders (MAHs), and patients directly.
Outcomes: The study examined Adverse Drug Reaction (ADR) reports of Clopidogrel products including brand and generic, patient who underwent percutaneous coronary interventions (PCI), and major cardiovascular events.

Results: During the study period, we identified 182 reports concerning Clopidogrel 19 cases (9.6%) are related to major cardiovascular events. 11 cases (6%) are life threating and one case resulted in death. Also, five cases (2.7%) reported as drug ineffective among patient who underwent percutaneous coronary interventions (PCI). Due to lack of information (Re-challenge, concomitant medications and genotype testing) all cases were considered possible.

Conclusions: The study results demonstrate several life threating cases and one death case among patients who underwent (PCI) after Clopidogrel administration. Extensive research should be conducted to evaluate the role of genotype testing in the region.