{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:20:21Z","timestamp":1777879221014,"version":"3.51.4"},"reference-count":17,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2015,5,25]],"date-time":"2015-05-25T00:00:00Z","timestamp":1432512000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2015,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>\n                      The objective of this study was to quantify the risk of intracranial hypertension (ICH) with the intrauterine levonorgestrel (IUL) device Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      We used the United States Food and Drug Administration\u2019s Adverse Events Reporting System (FAERS) database to quantify a reporting odds ratio (ROR) for ICH and Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . We also conducted a retrospective cohort study using the IMS LifeLink\n                      <jats:sup>\u00ae<\/jats:sup>\n                      database, comparing the risk of two oral contraceptives ethinyl estradiol (EE) with Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . A Bayesian sensitivity analysis was performed to account for the effect of body mass index (BMI).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The reported odds ratios (ORs) for ICH and papilledema with Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      were 1.78 (95% confidence interval [CI] 1.41\u20132.25) and 1.50 (95% CI 1.10\u20132.05), respectively. In the cohort study, the OR for ICH and EE-norgestimate and EE-norethindrone compared with Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      were 1.29 (95% CI 0.83\u20132.00) and 0.31 (95% CI 0.04\u20132.29), respectively. The presence of a strong confounder BMI did not affect the estimated OR (OR = 1.31, 95% CI 0.73\u20132.41 for EE-norgestimate; OR = 0.18, 95% CI 0.01\u20131.27 for EE-norethindrone).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>\n                      We found a higher than expected number of reports of ICH with Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      in the FAERS database. We also found a similar risk of ICH with Mirena\n                      <jats:sup>\u00ae<\/jats:sup>\n                      compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2042098615588084","type":"journal-article","created":{"date-parts":[[2015,5,26]],"date-time":"2015-05-26T20:00:12Z","timestamp":1432670412000},"page":"110-113","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":14,"title":["Risk of intracranial hypertension with intrauterine levonorgestrel"],"prefix":"10.1177","volume":"6","author":[{"given":"Mahyar","family":"Etminan","sequence":"first","affiliation":[{"name":"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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Statistics, University of British Columbia, Vancouver, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Gustafson","sequence":"additional","affiliation":[{"name":"Department of Statistics, University of British Columbia, Vancouver, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2015,5,25]]},"reference":[{"key":"bibr1-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199506223322519"},{"key":"bibr2-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1038\/sj.eye.6702245"},{"key":"bibr3-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-2299"},{"key":"bibr4-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1080\/09513590802444167"},{"key":"bibr5-2042098615588084","unstructured":"dailymed (2014) MIRENA \u2013 levonorgestrel intrauterine device. https:\/\/dailymed.nlm.nih.gov\/dailymed\/archives\/fdaDrugInfo.cfm?archiveid=12313 (accessed 2 October 2014)."},{"key":"bibr6-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1080\/09513590903159656"},{"key":"bibr7-2042098615588084","unstructured":"Medscape (2014) Idiopathic intracranial hypertension. http:\/\/emedicine.medscape.com\/article\/1214410-overview#a0156 (accessed 2 October 2014)."},{"key":"bibr8-2042098615588084","unstructured":"FDA (2014) FDA Adverse Event Reporting System (FAERS). http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/default.htm (accessed 2 October 2014)."},{"key":"bibr9-2042098615588084","unstructured":"IMS (2014) IMS LifeLink\u2122 Information Assets Electronic Medical Records. http:\/\/www.imshealth.com\/deployedfiles\/ims\/Global\/Content\/Solutions\/Healthcare%20Analytics%20and%20Services\/Healthcare%20Outcomes\/IMSLifelink-EMR.pdf (accessed 13 October 2014)."},{"key":"bibr10-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1007\/BF01849346"},{"key":"bibr11-2042098615588084","doi-asserted-by":"crossref","first-page":"131","DOI":"10.3109\/01658107.2010.485833","volume":"34","author":"Martinez H.","year":"2010","journal-title":"Neuroophthalmology"},{"key":"bibr12-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2711"},{"key":"bibr13-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.1982.tb01625.x"},{"key":"bibr14-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-7824(89)80008-3"},{"key":"bibr15-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ijo.0800758"},{"key":"bibr16-2042098615588084","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3181a819a1"},{"key":"bibr17-2042098615588084","doi-asserted-by":"crossref","unstructured":"Sheehan J. (1982) Hormone replacement treatment and benign intracranial hypertension 284(6330): 1675\u20131676.","DOI":"10.1136\/bmj.284.6330.1675"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042098615588084","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2042098615588084","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042098615588084","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:38:08Z","timestamp":1777592288000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2042098615588084"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,5,25]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2015,6]]}},"alternative-id":["10.1177\/2042098615588084"],"URL":"https:\/\/doi.org\/10.1177\/2042098615588084","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,5,25]]}}}