A real-world pharmacovigilance study of FDA adverse event reporting system events for sildenafil
© 2023 American Society of Andrology and European Academy of Andrology..
BACKGROUND: Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation.
METHODS: This retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case/non-case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil-related AEs.
RESULTS: Among 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life-threatening events, were reported. Significant system organ class (SOC) included "Reproductive system and breast disorders" (SOC: 10038604), "Neoplasms benign, malignant and unspecified" (SOC: 10038738), "Vascular disorders" (SOC: 10047065), and "Blood and lymphatic system disorders" (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included "Vision blurred," "Flushing," "sudden hearing loss," "Painful erection," and "Priapism." Unexpected AEs, such as "Malignant melanoma," "Pulmonary hypertension," "Malignant melanoma in situ," "Pulmonary arterial hypertension," "Metastatic malignant melanoma," "Malignant melanoma stage III," "Malignant melanoma stage II," "Acquired hemophilia," "Aortic dissection rupture," and "Intracranial artery dissection" were also identified.
CONCLUSIONS: These findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
|---|---|
| Enthalten in: |
Andrology - 12(2024), 4 vom: 25. Apr., Seite 785-792 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Wang, Yan [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Adverse event |
|---|
| Anmerkungen: |
Date Completed 12.04.2024 Date Revised 12.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1111/andr.13533 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362215278 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362215278 | ||
| 003 | DE-627 | ||
| 005 | 20240412232507.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/andr.13533 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1373.xml |
| 035 | |a (DE-627)NLM362215278 | ||
| 035 | |a (NLM)37724699 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Wang, Yan |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A real-world pharmacovigilance study of FDA adverse event reporting system events for sildenafil |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.04.2024 | ||
| 500 | |a Date Revised 12.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 American Society of Andrology and European Academy of Andrology. | ||
| 520 | |a BACKGROUND: Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation | ||
| 520 | |a METHODS: This retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case/non-case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil-related AEs | ||
| 520 | |a RESULTS: Among 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life-threatening events, were reported. Significant system organ class (SOC) included "Reproductive system and breast disorders" (SOC: 10038604), "Neoplasms benign, malignant and unspecified" (SOC: 10038738), "Vascular disorders" (SOC: 10047065), and "Blood and lymphatic system disorders" (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included "Vision blurred," "Flushing," "sudden hearing loss," "Painful erection," and "Priapism." Unexpected AEs, such as "Malignant melanoma," "Pulmonary hypertension," "Malignant melanoma in situ," "Pulmonary arterial hypertension," "Metastatic malignant melanoma," "Malignant melanoma stage III," "Malignant melanoma stage II," "Acquired hemophilia," "Aortic dissection rupture," and "Intracranial artery dissection" were also identified | ||
| 520 | |a CONCLUSIONS: These findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a FAERS database | |
| 650 | 4 | |a adverse event | |
| 650 | 4 | |a data mining | |
| 650 | 4 | |a pharmacovigilance | |
| 650 | 4 | |a sildenafil | |
| 650 | 7 | |a Sildenafil Citrate |2 NLM | |
| 650 | 7 | |a BW9B0ZE037 |2 NLM | |
| 700 | 1 | |a Zhao, Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Haiyan |e verfasserin |4 aut | |
| 700 | 1 | |a Wan, Zheng |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Andrology |d 2013 |g 12(2024), 4 vom: 25. Apr., Seite 785-792 |w (DE-627)NLM223616559 |x 2047-2927 |7 nnns |
| 773 | 1 | 8 | |g volume:12 |g year:2024 |g number:4 |g day:25 |g month:04 |g pages:785-792 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/andr.13533 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 12 |j 2024 |e 4 |b 25 |c 04 |h 785-792 | ||