Abstracts of the 2010 Meeting of the International Neuro-Ophthalmology Society, Lyon, France

Objectives: The objective of this study was to quantify the risk of intracranial hypertension (ICH) with the intrauterine levonorgestrel (IUL) device Mirena ® . Methods: We used the United States Food and Drug Administration's Adverse Events Reporting System (FAERS) database to quantify a reporting odds ratio (ROR) for ICH and Mirena ® . We also conducted a retrospective cohort study using the IMS LifeLink ® database, comparing the risk of two oral contraceptives ethinyl estradiol (EE) with Mirena ® . A Bayesian sensitivity analysis was performed to account for the effect of body mass index (BMI). Results:The reported odds ratios (ORs) for ICH and papilledema with Mirena ® were 1.78 (95% confidence interval [CI] 1.41-2.25) and 1.50 (95% CI 1.10-2.05), respectively. In the cohort study, the OR for ICH and EE-norgestimate and EE-norethindrone compared with Mirena ® were 1.29 (95% CI 0.83-2.00) and 0.31 (95% CI 0.04-2.29), respectively. The presence of a strong confounder BMI did not affect the estimated OR (OR = 1.31, 95% CI 0.73-2.41 for EEnorgestimate; OR = 0.18, 95% CI 0.01-1.27 for EE-norethindrone). Conclusion: We found a higher than expected number of reports of ICH with Mirena ® in the FAERS database. We also found a similar risk of ICH with Mirena ® compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated.

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Abstracts of the 2010 Meeting of the International Neuro-Ophthalmology Society, Lyon, France

Cited by 3 publications

References 271 publications

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Risk of intracranial hypertension with intrauterine levonorgestrel

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