Risk of Major Congenital Malformations Associated with the Use of Japanese Traditional (Kampo) Medicine Containing Ephedra During the First Trimester of Pregnancy

Autor: Aoi Noda, Taku Obara, Fumiko Matsuzaki, Satoko Suzuki, Ryutaro Arita, Minoru Ohsawa, Ryo Obara, Kei Morishita, Fumihiko Ueno, Genki Shinoda, Masatsugu Orui, Keiko Murakami, Mami Ishikuro, Akiko Kikuchi, Shin Takayama, Tadashi Ishii, Hiroshi Kawame, Shigeo Kure, Shinichi Kuriyama
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Drugs - Real World Outcomes, Vol 11, Iss 2, Pp 263-272 (2024)
Druh dokumentu: article
ISSN: 2199-1154
2198-9788
DOI: 10.1007/s40801-023-00411-0
Popis: Abstract Background Japanese traditional (Kampo) medicines containing ephedra may be used to treat colds during pregnancy. There are reports that ephedrine, a component of ephedra, has a risk of teratogenicity; however, the evidence remains equivocal. Objective This study aimed to evaluate the risk of major congenital malformations (MCMs) associated with exposure to Kampo medicines containing ephedra during the first trimester of pregnancy using the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study). Methods To 23,730 mother–infant pairs who participated in the TMM BirThree Cohort Study from July 2013 to March 2017, questionnaires in early and middle pregnancy were distributed approximately at weeks 12 and 26 of pregnancy, respectively. Infants' risk of MCMs in women who used Kampo medicines containing ephedra or acetaminophen during the first trimester was assessed, and the odds ratios (ORs) were estimated with unadjusted and adjusted analyses. Results Among 20,879 women, acetaminophen and Kampo medicines containing ephedra were used in 665 (3.19%) and 376 (1.80%) women, respectively, in the first trimester. Among the infants born to the mothers who used acetaminophen or Kampo medicine containing ephedra during the first trimester, 11 (1.65%) and 8 (2.13%), respectively, had overall MCMs. OR of overall MCMs was higher in women who used Kampo medicines containing ephedra than in those who used acetaminophen in the first trimester (adjusted OR, 1.45; 95% confidence interval (CIs), 0.57–3.71); however, the difference was not statistically significant. Conclusions In this study, there was no statistically significant association between the use of Kampo medicines containing ephedra during the first trimester of pregnancy and the risk of MCMs. Although some point estimates of ORs exceeded 1.00, the absolute magnitude of any increased risks would be low.
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