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資料１－３ ニフェジピン 調査結果報告書及び添付文書 (46 ページ)
出典
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会（令和4年度第19回 11／22）《厚生労働省》 |
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offspring of women with both untreated and treated chronic hypertension, respectively. The specific
mechanism involved is unclear, but it does not appear to be simply because of a teratogenic effect
from medication. The authors of a case– control study based on registry data confirmed the above
findings supporting the hypothesis that physiological changes early in pregnancy among women with
chronic hypertension may play a role in the etiology of cardiac septal defects, hypospadias, and
esophageal atresia.
海外ガイドライン 米国循環器学会・米国心臓協会・米国高血圧学会他
(8) Whelton PK et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA
Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in
Adults. A Report of the American College of Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines. Circulation. 2018; Oct 23;138(17):e426-e483. doi:
10.1161/CIR.0000000000000597.
10.2.2 Pregnancy
Recommendations for Treatment of Hypertension in Pregnancy
1. Women with hypertension who become pregnant, or are planning to become pregnant, should be
transitioned to methyldopa, nifedipine, and/or labetalol during pregnancy.
2. Women with hypertension who become pregnant should not be treated with ACE inhibitors, ARBs,
or direct renin inhibitors.
海外ガイドライン 欧州高血圧学会・欧州心臓病学会
(9) Williams B et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J
. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339
8.9Women, pregnancy, oral contraception, and hormonereplacement therapy
36
45
mechanism involved is unclear, but it does not appear to be simply because of a teratogenic effect
from medication. The authors of a case– control study based on registry data confirmed the above
findings supporting the hypothesis that physiological changes early in pregnancy among women with
chronic hypertension may play a role in the etiology of cardiac septal defects, hypospadias, and
esophageal atresia.
海外ガイドライン 米国循環器学会・米国心臓協会・米国高血圧学会他
(8) Whelton PK et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA
Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in
Adults. A Report of the American College of Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines. Circulation. 2018; Oct 23;138(17):e426-e483. doi:
10.1161/CIR.0000000000000597.
10.2.2 Pregnancy
Recommendations for Treatment of Hypertension in Pregnancy
1. Women with hypertension who become pregnant, or are planning to become pregnant, should be
transitioned to methyldopa, nifedipine, and/or labetalol during pregnancy.
2. Women with hypertension who become pregnant should not be treated with ACE inhibitors, ARBs,
or direct renin inhibitors.
海外ガイドライン 欧州高血圧学会・欧州心臓病学会
(9) Williams B et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J
. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339
8.9Women, pregnancy, oral contraception, and hormonereplacement therapy
36
45