A Real-World Pharmacovigilance Analysis of Lorlatinib-Associated Metabolic Effects Using the FDA Adverse Events Reporting System (FAERS) Database From 2013 to 2024
Authors' conclusion
These findings highlight the need for proactive monitoring and management of metabolic side effects in patients receiving lorlatinib. A multidisciplinary approach-incorporating pharmacologic interventions, lifestyle modifications, and regular monitoring-is essential to mitigate metabolic risks. This study enhances the understanding of lorlatinib's safety profile and informs clinical strategies to balance efficacy and tolerability in ALK inhibitor therapy.
Study context
- Population
- Reports of lorlatinib-associated metabolic adverse events in the FDA Adverse Event Reporting System
- Outcome
- Lorlatinib-associated metabolic adverse events (ROR)
Methodological detailsdisproportionality analysis of the FDA Adverse Event Reporting System, real-world
- Disproportionality analysis of the FDA Adverse Event Reporting System
- Real-world
Main finding
As reported in the abstract
- Hypercholesterolemia, ROR
- 98.46 (95% CI 79.28-122.29)
- Hypertriglyceridemia, ROR
- 66.10 (95% CI 49.60-88.11)
- Increased BMI, ROR
- 81.57 (95% CI 48.87-136.14)
- Increased blood cholesterol, ROR
- 23.42 (95% CI 19.69-27.86)
- Increased blood triglycerides, ROR
- 28.14 (95% CI 22.15-35.75)
- Dyslipidemia, ROR
- 53.60 (95% CI 38.51-74.60)
Original publication
A Real-World Pharmacovigilance Analysis of Lorlatinib-Associated Metabolic Effects Using the FDA Adverse Events Reporting System (FAERS) Database From 2013 to 2024. Endocr Pract. Published 24 April 2025. doi:10.
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