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15 February 2025

New Study Reveals Troubling Adverse Events Linked To Trazodone

Analysis of FDA data uncovers risks such as suicide and priapism associated with the common antidepressant trazodone.

A recent study investigating the safety profile of trazodone, an antidepressant developed over six decades ago, reveals concerning insights based on data from the FDA Adverse Event Reporting System (FAERS). This pharmacovigilance study explored over 5,199 adverse event reports concerning trazodone, shedding light on unexpected potential adverse reactions, including high incidences of suicide and priapism.

Since its introduction as the first non-tricyclic antidepressant approved by the FDA, trazodone has been primarily used for the treatment of major depressive disorder. Despite its standing as one of the more commonly prescribed antidepressants, its side-effect profile remains of significant concern, with this study seeking to comprehensively assess reports within the FDA's adverse events database spanning two decades.

The researchers extracted and analyzed data from the FAERS database between the first quarter of 2004 and the second quarter of 2024. Interestingly, the reports revealed notable gender and age dynamics: 52.68% of adverse events were reported by females, and the age group most represented was individuals aged 50 to 60 years. These demographic insights can serve as indicators for healthcare providers about the populations they must closely monitor for adverse reactions.

During the analysis, 179 significant adverse event signals were unearthed, with the study identifying not only commonly recognized side effects such as sedation and dizziness, but alarming new concerns: suicide, formulation toxicity, abnormal penile erection (priapism), and cardiac arrest. These findings were particularly disconcerting as they were not fully aligned with the drug's labeling information, which emphasizes the need for clinicians to remain vigilant and informed about potential unforeseen risks associated with trazodone.

One of the primary adverse events highlighted was completed suicide, which relies heavily on the underlying depression of patients. Trazodone is often prescribed to mitigate the symptoms of major depressive disorder; researchers cautioned, "Suicidal ideation was significantly associated with the severity of depression in half of the clinically depressed patients." This connection suggests heightened suicide risk, especially early within the treatment phase, underscoring the necessity for monitoring during this period.

Priapism, another unexpected finding linked to trazodone, emerged as the most frequently reported reproductive-related adverse event. The study noted, "Priapism may manifest during long-term treatment as well as at the first administration." Given its potential to cause significant injury or permanent effects if untreated, physicians must inform patients about the associated risks and advocate for immediate intervention if they encounter symptoms.

The researchers employed multiple statistical algorithms to draw these conclusions, leveraging disproportionality measures such as the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN). The comprehensive approach ensured the analysis minimized bias and facilitated the detection of signals relating to rare events, enhancing the reliability of the findings.

Overall, the results paint trazodone’s safety profile as more complex than traditional views suggest. The established link between depression and cardiac complications raised questions about the long-standing reputation of trazodone's cardiovascular safety. The study's authors detail potential cardiac risks, indicating potencial adverse outcomes associated with prolonged QT intervals, which could, under certain circumstances, lead to arrhythmias or cardiac arrest.

Crucially, the study concluded with important recommendations for clinical practice, emphasizing the necessity for regular monitoring and assessment of patients prescribed trazodone. The identification of multiple serious adverse effects not typically included on drug labels highlights the need for more rigorous pharmacovigilance efforts.

Given these findings, the authors advocate for the continuation of thorough prospective studies and audits to validate the safety data of trazodone, with the ultimate goal of ensuring patient safety through informed prescribing practices. Stringent monitoring protocols may be necessary, especially for at-risk populations, until more definitive data about trazodone's long-term safety profile is amassed.