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Albert Li; FDA Adverse Event Reports of Retinal Vascular Occlusions Associated with Combined Hormonal Contraceptive Vaginal Ring Use. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5309.
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© ARVO (1962-2015); The Authors (2016-present)
Combined hormonal contraceptives (CHC) have a known association with an increased risk of thromboembolic and thrombotic disease. Ocular manifestations of this risk, such as retinal vascular occlusions, are rare and have been reported in oral CHC use. However, the prevalence of retinal vascular occlusions is not well characterized for newer delivery methods, such as implanted CHC. This study compiled all retinal vascular occlusions reported to the FDA as adverse effects of NuvaRing (etonogestrel/ethinyl estradiol), a CHC vaginal ring.
Reports of all adverse effects associated with etonogestrel/ethinyl estradiol were obtained from the FDA Adverse Event Reporting System from its initial FDA approval in October 2001 through the end of December 2016. Cases reporting retinal artery occlusion (RAO) or retinal vein occlusion (RVO) were reviewed, excluding cases in which the diagnosis was confounded by other adverse events reported concurrently.
Among a total 15,526 reported adverse events associated with etonogestrel/ethinyl estradiol, there were 10 RVO, 2 combined RVO and RAO, and 3 RAO. Among these 15 cases of retinal vascular occlusions, 1 was reported to the FDA in 2010, 2 in 2011, 4 in 2013, 7 in 2014 and 1 in 2015.
Retinal vascular occlusions constitute less than 0.1% of all adverse event reports associated with etonogestrel/ethinyl estradiol that were reported to the FDA. Informed consent for implantable CHC may need to include a discussion of rare vision-threatening adverse events in the context of an increased risk for thromboembolic and thrombotic disease. Given that the first report of a retinal vascular occlusion associated with a CHC vaginal ring occurred over 8 years since its initial FDA approval, long-term monitoring may be necessary to capture such rare adverse events in future research.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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