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10-year Analysis of Adverse Event Reports to the Food and Drug Administration Related to the use of Phosphodiesterase Type-5 Inhibitors
Gregory Lowe, Raymond Costabile
University of Virginia, Charlottesville, VA

Introduction: To ensure public safety all Food and Drug Administration (FDA) approved medications undergo post-approval safety analysis. Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective.
Methods: We performed a non-industry sponsored analysis of the reports for sildenafil, tadalafil, and vardenafil to evaluate the overall cardiovascular and mortality events in the past 10 years. Summarized reports of adverse events for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA. These data are available under the Freedom of Information Act and document the reports of adverse events entered into the computerized system maintained by the Office of Surveillance and Epidemiology. The data was analyzed for overall number of adverse events (AEs), number of Objective cardiovascular events, and reported deaths.
Results: Overall 14818 AEs were reported for sildenafil. Events associated with death numbered 1824 (12.3%) and those associated with cardiovascular adverse events numbered 2406 (16.2%). Tadalafil was associated with 5548 AEs and those associated with cardiovascular adverse events and deaths were 7.8% and 4.3% of these reports respectively. Vardenafil was associated with 6085 events, with cardiovascular adverse events and deaths at 5.3% and 2% respectively. Only 10% of adverse events were reported by the manufacturers.
Conclusion: Adverse events associated with death are concerning and remain above 5% of total reported events. Limitations of this data set exist but it is important that these reports be reviewed outside of the pharmaceutical industry in order to provide due diligence and transparency.


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