Safety of cardiovascular disease drugs approved between 2014 and 2021 in the US: a pharmacovigilance analysis

ABSTRACT

Background

Recently FDA-approved drugs for cardiovascular disease (CVD) require robust post-marketing surveillance. The objective of this study was to assess their safety using a large pharmacovigilance database.

Research design and methods

We analyzed adverse event (AE) reports for 17 drugs approved from 2014 to 2021, utilizing the FDA Adverse Event Reporting System (FAERS). Descriptive and disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and its 95% confidence interval.

Results

Among the 43,664,773 AE reports 97,702 (0.22%) were related to newly approved CVD drugs. No AEs were reported for finerenone and evinacumab. The results from the disproportionality analyses revealed potential risks of acute kidney injury (ROR = 8.24, 95% CI: 6.05–11.22), cardiac failure (ROR = 4.80, 95% CI: 3.82–6.05), and hypotension (ROR = 3.98, 95% CI: 3.44–4.61) among sacubitril/valsartan users. Additionally, ivabradine was found to be associated with tachycardia (ROR = 11.94, 95% CI: 8.35–17.08), abnormal feeling (ROR = 4.40, 95% CI: 2.70–7.18), and dizziness (ROR = 2.56, 95% CI: 1.68–3.90).

Conclusions

This study identified specific safety concerns related to recently approved CVD drugs. Further research is required to understand the underlying mechanisms and clinical implications of these findings.

KEYWORDS:

• Adverse reactions
• cardiovascular drugs
• FDA adverse event reporting system (FAERS)
• pharmacovigilance
• post-marketing surveillance

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution

All authors contributed to the study’s conception and design. T Park was primarily responsible for statistical analyses. All authors jointly drafted the manuscript, critically revised it for intellectual content, and unanimously approved its final version for publication. All authors agree to be accountable for all aspects of the work.

Additional information

Funding

This paper was not funded.