September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
FDA Adverse Event Reports of Retinal Vascular Occlusions Associated with PDE5 Inhibitor Use
Author Affiliations & Notes
  • Albert Li
    North Shore-Long Island Jewish Health System, Huntington Station, New York, United States
  • Howard Pomeranz
    North Shore-Long Island Jewish Health System, Huntington Station, New York, United States
  • Footnotes
    Commercial Relationships   Albert Li, None; Howard Pomeranz, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2045. doi:
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      Albert Li, Howard Pomeranz; FDA Adverse Event Reports of Retinal Vascular Occlusions Associated with PDE5 Inhibitor Use. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2045.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Phosphodiesterase type 5 inhibitors (PDE5I), prescribed for treatment of erectile dysfunction and pulmonary hypertension, have been associated with ocular adverse effects. At least 8 cases of retinal vascular occlusions associated with PDE5I have been published in the peer-reviewed literature, but the prevalence of retinal vascular occlusions is unknown. This study compiled all retinal vascular occlusions reported to the FDA as adverse effects of PDE5I.

Methods : Reports of all adverse effects associated with sildenafil (Viagra), vardenafil (Levitra), tadalafil (Cialis) and avanafil (Stendra) were obtained from the FDA Adverse Event Reporting System, from their initial FDA approval until the end of 2014. Cases reporting retinal artery occlusion (RAO) or retinal vein occlusion (RVO) were reviewed, excluding cases in which the diagnosis was confounded by other ocular adverse events reported concurrently. This determination was made by consensus of two reviewers.

Results : Among over 31,000 adverse events reported since March 1998, sildenafil was associated with 82 RVOs and 24 RAOs. Among 7,550 adverse events since August 2003, vardenafil was associated with 7 RVOs and 4 RAOs. Among 5,569 adverse events since November 2003, tadalafil was associated with 24 RVOs and 10 RAOs. There were no retinal vascular occlusions associated with avanafil among the 123 adverse events reported since April 2012. Upon reviewing the listed medications for each case, 39.8% of all PDE5I-associated RVOs and 47.3% of all PDE5I-associated RAOs were on an antihypertensive, antidiabetic, antihyperlipidemic, antiplatelet, or antithrombotic agent.

Conclusions : A total of 113 RVOs and 38 RAOs associated with PDE5I use were identified in the FDA database, significantly greater than the number reported in the literature. Approximately 40% of these cases were taking medications for other conditions that could contribute to a retinal vascular occlusion such as diabetes, hypertension and hyperlipidemia. Further research is necessary to determine whether retinal vascular occlusions associated with PDE5I use are isolated events or in part due to concurrent underlying medical conditions.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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