Population-scale identification of differential adverse events before and during a pandemic

Abstract

Adverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019. A nationwide pandemic (such as COVID-19) further challenges the ability of healthcare systems to ensure safe medication use and the pandemic’s effects on safety events remain poorly understood. Here, we investigate drug safety events across demographic groups before and during a pandemic using a dataset of 1,425,371 reports involving 2,821 drugs and 7,761 adverse events. Among 64 adverse events identified by our analyses, we find 54 increased in frequency during the pandemic, despite a 4.4% decrease in the total number of reports. Out of 53 adverse events with a pre-pandemic gender gap, 33 have seen their gap increase with the pandemic onset. We find that the number of adverse events with an increased reporting ratio is higher in adults (by 16.8%) than in older patients. Our findings have implications for safe medication use and preventable healthcare inequality in public health emergencies.

Multimodal representation learning for predicting molecule–disease relations

“…Each drug is typically reported to have some indications or side effects, often noted in the widely used SIDER ( Liu et al , 2012 ) and FDA reports ( Zhang et al , 2021 ), which constitute the positive drug–disease pairs. However, validated annotations on negative drug–disease relationship pairs are scarce.…”

“…The same three settings as in the molecule indication prediction are used. For mono-drug side effects, we experiment on SIDER(Liu) ( Liu et al , 2012 ), SIDER(Zhang) ( Zhang et al , 2015 ), nd SIDER-FAERS(mono) which aims for cross-year validation by learning on SIDER 4.1 ( Kuhn et al , 2016 ) with annotated drugs marketed before 2015 and evaluating on FAERS2021 ( Zhang et al , 2021 ) with newly marketed drugs since 2015. For side effects by drug–drug interactions, we evaluate on TWOSIDES ( Zitnik et al , 2018 ), following the protocols of Yu et al (2021) and FAERS2021 ( Zhang et al , 2021 ).…”

Considerations and Challenges for Sex-Aware Drug Repurposing

“…Therefore, it is difficult to determine if a drug causes an adverse event. However, it is possible to estimate disproportionality or calculate odds ratios to identify associations between drugs and adverse events (17).…”

“…Adverse events, defined by the FDA as any undesirable experience using a medical product in a patient (16), are the fourth leading cause of death in the United States and can be caused by many factors such as tissue differences, age, development, and race (3,17). However, in 2001, eight of the ten drugs recalled by the FDA were more significant health risks to women than men (18).…”

“…This recall led to several studies that found that women are twice as likely to experience an adverse drug event compared to men based on adverse drug event case reports from the Food Drug Administration's Adverse Event Reporting System (FAERS) or World Health Organization's VigiBase database (3,5,19,20). Recently, during the coronavirus disease of 2019 (COVID-19) pandemic, there was an increase in the sex-bias adverse event (SBAEs) gap between females and males, possibly due to the pandemic exacerbating known SBAEs such as anxiety (17). Even though SBAEs are more common in females, males are more likely to have a severe drug adverse event than females (20).…”