Risk of intracranial hypertension with intrauterine levonorgestrel

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 EE-norgestimate; 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.