OBJECTIVES: To evaluate the safety profiles of 10 cardiovascular disease (CVD) drugs approved by the FDA between 2014 and 2021.

METHODS: The study utilized the FDA Adverse Event Reporting System (FAERS) database to identify adverse event (AE) reports associated with the ten CVD drugs from the first quarter (Q1) of 2014 through Q1 of 2023, allowing for a two-year buffer following drug approvals to accumulate AE reports. These drugs were compared to comparator drugs approved before 2014 to assess AE reporting trends between recently approved drugs (2014-2021) and the comparator drugs. A disproportionality analysis of AEs was conducted by estimating the reporting odds ratio (ROR) and its confidence interval.

RESULTS: Out of 43,664,773 AE reports, 20,267 were relevant and included in the analysis. In comparison to valsartan, sacubitril/valsartan exhibited significantly higher reports of hypotension (ROR=2.22, 95% CI: 1.28–3.84) and neurological disorders (ROR=2.76, 95% CI: 1.54–4.94) among females. The risk of neurological disorders was also elevated for adults aged 18-64 (ROR=2.11, 95% CI: 1.29–3.44). Furthermore, ivabradine users were more likely to report cardiac arrhythmias compared to valsartan users (ROR=2.18, 95% CI: 1.05–4.56). Subgroup analyses indicated that ivabradine was associated with cardiac arrhythmias irrespective of gender and age, with RORs ranging from 2.08 to 4.89. Ivabradine also exhibited potential risks of neurological disorders among female patients (ROR=3.31, 95% CI: 1.85–5.92) and adults aged 18-64 (ROR=2.42, 95% CI: 1.41–4.15). For other CVD drugs included in this study, additional data accumulation is essential to gain further insights into the AEs associated with these medications.

CONCLUSIONS: This study contributes real-world evidence regarding the safety profiles of the recently approved CVD drugs. Further research is necessary to better understand the specific mechanisms underlying these safety concerns and to confirm their clinical significance.