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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1481378
This article is part of the Research Topic Pharmacoepidemiology in Chronic Diseases View all 3 articles

Anti-migraine medications safety during pregnancy in the US

Provisionally accepted
Anick Bérard Anick Bérard 1,2*Shannon Strom Shannon Strom 3Detlef Albrecht Detlef Albrecht 3Shashi Kori Shashi Kori 3
  • 1 Montreal University, Montreal, Canada
  • 2 CHU Sainte Justine Research Center, University of Montreal, Montréal, Quebec, Canada
  • 3 Satsuma Pharmaceuticals, San Francisco, United States

The final, formatted version of the article will be published soon.

    Background: Specific antimigraine medications (DHE and triptans) have been associated with adverse pregnancy outcomes in individual studies but lack of consensus remains. Objectives: Quantify the risk of prematurity, low birth weight (LBW), major congenital malformations (MCM), and spontaneous abortions (SA) associated with gestational use of dihydroergotamine (DHE) or triptans in a privately insured cohort of pregnant women in the US. Methods: We conducted a cohort study within the US Merative MarketScan Research Database (2011–2021), composed of a nationally representative sample of patients with employer-provided health insurance. Four independent analyses were conducted to assess the risk of 1) prematurity (<37 weeks of gestation), 2) LBW (birth weight <2,500 g), 3) MCM, and 4) clinically detected SA. Exposure was defined dichotomously as use of DHE or triptan during pregnancy. Generalized estimation equations (GEE) were built to quantify the associations taking into account potential confounders including maternal migraine. Results: Overall, 767,994 pregnant women met eligibility criteria and were included in the analyses on prematurity, LBW, and MCM; 11,121 cases of SA were identified and analyzed. One hundred and eighty-nine (189 (0.02%)) were exposed to DHE (all in the first trimester), and 4,309 (0.56%) to triptans. Adjusting for potential confounders including maternal migraine, DHE was not associated with a statistically significant risk of prematurity (adjusted RR (aRR) 1.17, 95%CI 0.14, 9.74), LBW (aRR 7.76, 95%CI 0.99, 60.83), MCM (aRR 2.27, 95%CI 0.97, 5.29), or SA (aOR 3.19, 95%CI 0.98, 10.38); DHE was associated with an increased risk of septal defects. All estimates were unstable. Similarly, triptan use was not associated with any of the studied outcomes. Discussions and conclusions: After considering maternal migraine and other potential confounders, DHE (first trimester) and triptan exposure during pregnancy were not statistically significantly associated with an increased risk for prematurity, LBW, MCM, or SA. Findings on septal defects could be due to chance, and need replication.

    Keywords: Migraine, Pregnancy, spontaneous abortion, Major congenital malformations, prematurity, low birth weight, Medications, US

    Received: 15 Aug 2024; Accepted: 11 Nov 2024.

    Copyright: © 2024 Bérard, Strom, Albrecht and Kori. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Anick Bérard, Montreal University, Montreal, Canada

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