title: Risk of intracranial hypertension with intrauterine levonorgestrel.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Mahyar
authors.initials: M
authors.lastname: Etminan
authors.affiliation: Department of Statistics, University of British Columbia, Vancouver, Canada.
authors.forename: Hao
authors.initials: H
authors.lastname: Luo
authors.affiliation: Department of Statistics, University of British Columbia, Vancouver, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Gustafson
keywords: cohort study; drug safety; intracranial hypertension; intrauterine levonorgestrel