Title: The safety of pranlukast and montelukast during the first trimester of pregnancy: A prospective, two‐centered cohort study in Japan

Abstract

Abstract For leukotriene receptor antagonists (LTRAs), especially pranlukast, safety data during pregnancy is limited. Therefore, we conducted a prospective, two‐centered cohort study using data from teratogen information services in Japan to clarify the effects of LTRA exposure during pregnancy on maternal and fetal outcomes. Pregnant women who being counseled on drug use during pregnancy at two facilities were enrolled. The primary outcome of this study was major congenital anomalies. The incidence of major congenital anomalies in women exposed to montelukast or pranlukast during the first trimester of pregnancy was compared with that of controls. Logistic regression analysis was performed to analyze the effects of maternal LTRA use during the first trimester of pregnancy on major congenital anomalies. The outcomes of 231 pregnant women exposed to LTRAs (montelukast n  = 122; pranlukast n  = 106; both n  = 3) and 212 live births were compared with those of controls. The rate of major congenital anomalies in the LTRA group was 1.9%. Multivariable logistic regression analysis revealed that LTRA exposure was not a risk factor for major congenital anomalies (adjusted odds ratio, 0.78; 95% confidence interval, 0.23–2.05; p  = 0.653). In addition, no significant difference was detected in stillbirth, spontaneous abortion, preterm birth, and low birthmore » weight between the two groups. The present study revealed that montelukast and pranlukast were not associated with the risk of major congenital anomalies. Our findings suggest that LTRAs could be safely employed for asthma therapy during pregnancy.« less

Authors:

Hatakeyama, Shiro  ^[1];

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Goto, Mikako ^[2]; Yamamoto, Ayaka ^[1]; Ogura, Jiro ^[1]; Watanabe, Norikazu  ^[3];

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Tsutsumi, Seiji ^[4]; Yakuwa, Naho ^[2]; Yamane, Ritsuko ^[5]; Nagase, Satoru ^[3]; Takahashi, Kunihiko ^[6]; Kosaki, Rika ^[7]; Murashima, Atsuko ^[8]; Yamaguchi, Hiroaki ^[1]

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+ Show Author Affiliations

1. Department of Pharmacy Yamagata University Hospital Yamagata Japan
2. The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development Tokyo Japan
3. Department of Obstetrics and Gynecology Yamagata University Faculty of Medicine Yamagata Japan
4. Department of Obstetrics and Gynecology Yamagata Prefecture Central Hospital Yamagata Japan
5. Department of Pharmacy Toranomon Hospital Tokyo Japan
6. Department of Biostatistics, M&,D Data Science Center Tokyo Medical and Dental University Tokyo Japan
7. Division of Medical Genetics National Center for Child Health and Development Tokyo Japan
8. The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development Tokyo Japan, Center of Maternal‐Fetal, Neonatal and Reproductive Medicine National Center for Child Health and Development Tokyo Japan

Publication Date:

2022-05-24

Sponsoring Org.:

USDOE

OSTI Identifier:

1877307

Resource Type:

Publisher's Accepted Manuscript

Journal Name:

Congenital Anomalies (1987)

Additional Journal Information:

Journal Name: Congenital Anomalies (1987) Journal Volume: 62 Journal Issue: 4; Journal ID: ISSN 0914-3505

Publisher:

Wiley-Blackwell

Country of Publication:

Japan

Language:

English