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Objective: To evaluate the association of concomitant topiramate and oral hormonal contraceptive use with unintended pregnancies., Study Design: We conducted a retrospective cohort design in MarketScan Research Databases (2005-2018) on women aged 12-48 who had migraines or chronic headaches and concomitantly used topiramate and oral contraceptives. We used a cohort of patients with oral contraceptives and concomitant use of other migraine prevention therapies (propranolol, metoprolol, amitriptyline, venlafaxine, or verapamil) as a comparator. We followed patients for up to 1 year from cohort entry to assess the occurrence of unintended pregnancy (i.e., contraception failure). Pregnancy events were measured via an algorithm harnessing medical encounters information with live births, terminations, or prenatal visits. Statistical models accounted for multiple cohort entries and adjusted for measured confounders via a propensity score weighting method., Results: We identified 63,649 episodes of oral contraceptives+topiramateand 59,012 episodes of oral contraceptives+other maintenance therapies. The mean age was 29.2±9.0 and 29.0±9.3 years in the study cohorts. In the adjusted analysis, the contraception failure rate (95% confidence interval) was 1.3 (1.1, 1.6) per 100 person-years in the oral contraceptives+topiramate cohort and 1.3 (1.1, 1.6) in the oral contraceptives+other maintenance therapies cohort. The adjusted rate ratio and rate difference measures were 1.00 (0.80, 1.26) and 0.00 (-0.3, 0.3)., Conclusion: Concomitant use of low-dose topiramate and oral contraceptives among patients with migraines was not associated with a higher risk for unintended pregnancies., Implications: Our real-world findings confirm clinical pharmacology trials, suggesting that low-dose (≤200 mg/d) topiramate may not influence oral contraceptive effectiveness., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To estimate associations between contraceptive failures and concomitant CYP3A4-inducing medications by route of administration., Study Design: Comparison of unintended pregnancy outcomes within U.S. Food and Drug Administration's Adverse Event Reporting System by couse of CYP3A4-inducing drugs and route of administration for levonorgestrel and etonogestrel/desogestrel., Results: Among 14,504 levonorgestrel case reports, the reporting odds ratio (ROR) was increased for oral (ROR = 4.2 [3.0-5.7]), implants (ROR = 8.0 [5.8-11.0]), but not intrauterine (ROR = 0.9 [0.6-1.3]) levonorgestrel products. For 9348 etonogestrel/desogestrel case reports, oral and vaginal products were not associated with contraceptive failure. Etonogestrel containing implants (ROR = 4.9 [4.1-5.9]) were associated with increased contraceptive failure., Conclusion: Levonorgestrel containing combination oral products and implants containing levonorgestrel or etonogestrel were prone to CYP3A4-inducing drug-drug interactions that may increase contraceptive failures., Implications: The progestin components of hormonal contraceptives are susceptible to drug-drug interactions, but this susceptibility is influenced by route of administration. This study provides evidence from an Adverse Event Reporting System that CYP3A4-inducing medications increase the risk of unintended pregnancy for oral and implant contraceptives but not intrauterine or vaginal devices., (Copyright © 2020. Published by Elsevier Inc.)