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Updated: May 16, 2026

Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
[Pregnancy outcomes of exposure to methimazole (POEM) study]
1Division of Internal Medicine (Diabetes and Endocrinology), Department of Women' s Health, National Center for Child Health and Development.
Abstract:
To elucidate whether incidence of malformation related to 'methimazole (MMI) embryopathy' is increasing associated with exposure to MMI in the first 12 gestational weeks, Graves' women(MMI group/propylthiouracil (PTU) group/non-antithyroidal drug (ATD) group) who noticed pregnancy were registered from several thyroid clinics to Japan Drug Information Institute in Pregnancy since 2008, we were now prospectively collecting outcomes of pregnancy. In June 2011, we announced the interim report which showed extremely higher incidence of MMI-related malformation than expected. Five cases of MMI-related embryopathy in 85 live births of MMI group (95% confidence interval: 1.9-13.2%), while none of this embryopathy was found in neither 121 live births of PTU group nor 83 of non-ATD group. We issued a joint statement with the Japan Thyroid Association about the recommendation to avoid the continuation of MMI during organogenesis period in Graves' women. The final report will be made by 2014.
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