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Adverse reactions of PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance database

Adverse reactions of PDE5 inhibitors: An analysis of the World Health Organization... INTRODUCTIONBy estimation, 322 million men will be affected by erectile dysfunction (ED) worldwide by 2025.1 The prevalence of ED increases with age, and national data show that as many as 70% of American men aged 70 years or older are affected.2 Oral phosphodiesterase type 5 inhibitors (PDE5is) are the most commonly used treatment for ED and are established in the guidelines as the first‐line therapy for patients with the disease.3,4 PDE5is are generally considered efficient and safe. Although the rate of adherence in PDE5i users is relatively low (59.6%–70.2%), fear of side effects seems to play a minor role in their decision to discontinue the medication.5Several severe, albeit rare, adverse drug reactions (ADRs) have been associated with oral PDE5is with limited understanding of prevalence: relationships between oral PDE5is and priapism and malignant melanoma have been explored recently.6 Although both ADRs are difficult to characterize, they highlight the importance of early identification and treatment. Histopathologic studies have suggested that PDE5is promote malignant melanoma cell growth through two separate signaling pathways that increase tumor invasiveness and survival.7,8 However, observational data fail to depict a causative association between PDE5is and malignant melanoma.9Pharmacovigilance databases collect reports of suspected ADRs by patients, healthcare professionals, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Andrology Wiley

Adverse reactions of PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance database

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Publisher
Wiley
Copyright
© 2023 American Society of Andrology and European Academy of Andrology.
ISSN
2047-2919
eISSN
2047-2927
DOI
10.1111/andr.13430
Publisher site
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Abstract

INTRODUCTIONBy estimation, 322 million men will be affected by erectile dysfunction (ED) worldwide by 2025.1 The prevalence of ED increases with age, and national data show that as many as 70% of American men aged 70 years or older are affected.2 Oral phosphodiesterase type 5 inhibitors (PDE5is) are the most commonly used treatment for ED and are established in the guidelines as the first‐line therapy for patients with the disease.3,4 PDE5is are generally considered efficient and safe. Although the rate of adherence in PDE5i users is relatively low (59.6%–70.2%), fear of side effects seems to play a minor role in their decision to discontinue the medication.5Several severe, albeit rare, adverse drug reactions (ADRs) have been associated with oral PDE5is with limited understanding of prevalence: relationships between oral PDE5is and priapism and malignant melanoma have been explored recently.6 Although both ADRs are difficult to characterize, they highlight the importance of early identification and treatment. Histopathologic studies have suggested that PDE5is promote malignant melanoma cell growth through two separate signaling pathways that increase tumor invasiveness and survival.7,8 However, observational data fail to depict a causative association between PDE5is and malignant melanoma.9Pharmacovigilance databases collect reports of suspected ADRs by patients, healthcare professionals,

Journal

Andrology – Wiley

Published: Mar 11, 2023

Keywords: erectile dysfunction; malignant melanoma; PDE5 inhibitor; priapism; sexual dysfunction; sildenafil

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