Mahyar Etminan1, Hao Luo2, Paul Gustafson2. 1. Therapeutic Evaluation Unit, Child and Family Research Institute of British Columbia, Faculty of Medicine, University of British Columbia, A4-198 WS 2, 709-650 West 28th Avenue, Vancouver, BC, Canada. 2. Department of Statistics, University of British Columbia, Vancouver, Canada.
Abstract
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.
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.
Entities:
Keywords:
cohort study; drug safety; intracranial hypertension; intrauterine levonorgestrel
Authors: Khin P Kilgore; Michael S Lee; Jacqueline A Leavitt; Ryan D Frank; Collin M McClelland; John J Chen Journal: Am J Ophthalmol Date: 2018-09-21 Impact factor: 5.258