Safety of four phosphodiesterase 5 inhibitors based on the FAERS database

doi:10.19803/j.1672-8629.20230073

Abstract

Abstract: Objective To mine real-world adverse event report data and analyze the post-marketing safety characteristics of four phosphodiesterase 5 (PDE5) inhibitors. Methods By searching the FDA Adverse Event Reporting System (FAERS), data on adverse drug event (ADE) reports of sildenafil, tadalafil, vardenafil, and avanafil as first suspected drugs were collected from the second quarter of 2012 to the third quarter of 2022, respectively, and standardized map analysis of systematic organ classification (SOC) and preferred term (PT) was performed. Valid disproportional measures signals of adverse drug reaction (ADR) were screened according to report-odds ratio (ROR) and information component (IC), and high-intensity ADR signals were analyzed. Results A total of 27 695 cases of sildenafil ADE, 16 683 cases of tadalafil, 718 cases of vardenafil and 222 cases of avanafil were found and included. The major types of SOC reported on the 4 drugs were similar. In terms of high-intensity ADR signals, the overall signal intensity (of ROR value) from largest to smallest was sildenafil, tadalafil, vardenafil, while no valid signal of avanafil was detected. The ADR signals of sildenafil were mainly concentrated in the reproductive system with multiple malignant skin tumor related ADR signals. The signal intensity of ADR related to malignant skin tumors of tadalafil was significantly higher than that of other drugs, and most of its high-intensity signals were not yet included in the specification. Vardenafil was mainly represented by diseases of reproductive system and eye organs. Conclusion The ADR signal strength of the four PDE5 inhibitors showed a decreasing trend with the time of marketing, but there were considerable differences in the specific characteristics. Targeted attention should be paid to the clinical application, and it is recommended to timely supplement and update the ADR information in the instructions of vardenafil and sildenafil.

Key words: phosphodiesterase 5, sildenafil, tadalafil, vardenafil, avanafil, adverse drug reaction, adverse drug event, safety

CLC Number:

CHEN Yakun, MEN Peng, WANG Pan. Safety of four phosphodiesterase 5 inhibitors based on the FAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 691-696.

References

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