Risk of intracranial hypertension with intrauterine levonorgestrel

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 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.

Intracranial hypertension after Chiari decompression resolving after removal of a levonorgestrel-releasing intrauterine device: case report

“…Levonorgestrel binds to sex hormone-binding protein (SHBP), the concentrations of which can vary among women, causing variable systemic concentrations. 3 Furthermore, serum levels of levonorgestrel have been shown to be similar between LIUDs and oral levonorgestrel formulations. 4 Idiopathic intracranial hypertension has also been shown to occur as a side effect after LIUD placement, 3 implying that LIUDs may, in fact, account for side effects similar to those of systemically administered progestin formulations.…”

“…Progestins have been associated with the development of IIH with an unknown mechanism. 1,3,4,7 In 1995 Alder et al reported on the risk of IIH in women implanted with subdermal levonorgestrel and found a total of 2 cases of IIH at their institution and an additional 56 cases in various databases. 1 Additionally, Chan described a case of symptomatic IIH 2 months after initiating depot medroxyprogesterone.…”

Pseudotumor Cerebri Following Nexplanon® Implantation

“…This controversy is amplified by the financial conflicts of interest present on both sides of the debate, as has been discussed in the literature [ 7 - 9 ]. Regardless of financial interests, patient safety must be paramount in any discussion.…”

Risk of intracranial hypertension with intrauterine levonorgestrel

“…I am concerned about the erroneous and misleading conclusions expressed by Etminan and colleagues in their article published in the June 2015 Issue of Therapeutic Advances in Drug Safety [Etminan et al 2015]. There are significant methodological flaws with this study that preclude accurate statistical analysis and interpretation of the data.…”