Recall Outcomes of Aspirin in Saudi Arabia: An Observational Study

Introduction: Aspirin or acetylsalicylic acid (ASA) at low doses is used as an antiplatelet blood-thinning agent to prevent heart attacks and stroke by reducing the risk of clot formation in the arteries. In January 21, 2019, a certain widely available generic of ASA was recalled from the Saudi market by the marketing authorization holder due to quality issues. Therefore, the widespread recall may have been challenging to healthcare institutions that were mostly dependent on this ASA generic for antiplatelet treatment, and subsequently may have affected patient care. In this study, we aim to describe patient management characteristics following the recall in terms of alternative therapy used, medication switching timeline, and health outcomes. Methods: Using electronic health records from Real-World Evidence Research Network, we identified patients who had been prescribed the concerned ASA during the 3 months before the recall announcement and after the recall. Descriptive secondary data analysis was employed to demonstrate management characteristics following ASA recall in terms of alternative therapy used, medication switching timeline and health outcomes. Results: A total of 32,019 patients had been prescribed ASA in the pre-recall period, of which 20,940 (65%) patients were followed up in the post-recall period and were included in the study. The vast majority of patients (98%) were prescribed a different ASA generic than the recalled ASA. Most patients had no recorded incidents of major adverse cardiovascular events in the post-recall period (99.5%). The median time to treatment switching to either another ASA generic or other antiplatelet medication was 31 days following the recall. Conclusion: Post-recall patient management appears to be considerably longer than the period clinically estimated for health complications occurrence after therapy discontinuation. Meaning, health complications may be expected to occur due to prolonged period of discontinued treatment that took place before patients were switched to alternative therapy. However, the vast majority of patients in this study have not been affected by health complications after the recall, and almost all patients have been switched to another ASA generic.