Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data.

Area of Science:

• Pharmacovigilance and Drug Safety
• Oncology and Endocrinology

Background:

• Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, is an FDA-approved medication for advanced prostate cancer, endometriosis, and central precocious puberty.
• Real-world adverse event (AE) profiling is crucial for understanding drug safety beyond clinical trials.

Purpose of the Study:

• To characterize the real-world adverse event (AE) profile of triptorelin.
• To identify potential statistical safety signals using a large adverse event database.

Main Methods:

• Retrospective pharmacovigilance study using FDA Adverse Event Reporting System (FAERS) data from 2004Q1-2024Q3.
• Disproportionality analysis with four algorithms (ROR, PRR, BCPNN, MGPS) to detect AE signals.
• Analysis of 4018 triptorelin suspect reports among 18.5 million FAERS reports.

Main Results:

• 102 statistically significant Preferred Terms (PTs) identified.
• Unexpected signals included defiant behavior and Alzheimer's dementia, meeting EMA criteria for further investigation.
• AEs showed a bimodal onset pattern, with distinct profiles between genders.

Conclusions:

• FAERS data revealed both expected and unexpected safety signals for triptorelin.
• Defiant behavior and Alzheimer's dementia represent significant potential safety concerns requiring clinical validation.
• Continuous pharmacovigilance is recommended to monitor triptorelin's safety profile.