Post-marketing pharmacovigilance study of inclisiran: mining and analyzing adverse event data from the FDA Adverse Event Reporting System database
Abstract
Background Inclisiran, the newest lipid-lowering drug, has not shown significant safety problems in major clinical studies. However, its recent market introduction and limited clinical use have produced few reports of adverse reactions, leaving a comprehensive understanding of its long-term safety yet to be established. Aim The aim of the study was to conduct a signal detection analysis of adverse events (AEs) associated with inclisiran using FDA Adverse Event Reporting System (FAERS) datasets. Method Data on AEs associated with inclisiran were collected from the FAERS database from 2021 to 2023. Signal detection was conducted using the reporting odds ratio (ROR) and the information component (IC). The analysis was standardized using the Medical Dictionary for Regulatory Activities (MedDRA) and focused on System Organ Classes (SOCs) and Preferred Terms. Results Of 17,307,196 AE reports, 2976 were relevant to inclisiran. The male-to-female ratio of these events was 0.74:1, predominantly in patients aged 45 to 74 years. A total of 102 AE signals associated with inclisiran were identified in 15 SOCs. Among these, 86 involved muscle injuries, liver injuries, diabetes, neurocognitive dysfunction, and other events not listed on the drug label. Conclusion The findings confirm all AEs documented on the drug label and in current clinical trials while also revealing new AEs such as muscle pain, elevated liver enzymes, increased blood glucose levels, and neurocognitive dysfunction. This…
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Rare hepatotoxicity, myopathy, or renal toxicity events were observed, and no concerning trends emerged from routine laboratory tests.
“Rare hepatotoxicity or myopathy or renal toxicity events were observed and no concerning trends emerged from routine laboratory tests [82, 83].”
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“Rare hepatotoxicity or myopathy or renal toxicity events were observed and no concerning trends emerged from routine laboratory tests [82, 83].”
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- Authors
- Zou, D., Hu, Q., Liu, Y., & Yu, L.
- Affiliations
- Sichuan University (CN)
- Corresponding author
- Yu, Lei
- Venue
- International Journal of Clinical Pharmacy
- Published
- 2024-08-27
- Volume
- 46
- Issue
- 6
- Pages
- 1419-1426
- ISSN
- 2210-7703 (ISSN-L)
- 2210-7711
- OpenAlex
- W4401907141
- Cited by
- 5
- References
- 33
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 1
- FWCI
- 1.18
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- International Journal of Clinical Pharmacy (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Natural Science Foundation of Sichuan Province (2023NSFSC1696)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- inclisiran, adverse drug reactions, signal detection, FDA Adverse Event Reporting System, lipid-lowering drugs, myalgia, elevated liver enzymes, hyperglycemia, neurocognitive impairment, drug safety
- MeSH terms
- Adolescent, Adult, Aged, Hypolipidemic Agents, Female, Humans, Male, Middle Aged, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration, Databases, Factual, Adverse Drug Reaction Reporting Systems, Young Adult, Data Mining, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions
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