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資料1-2 国内外の診療ガイドライン等の記載状況 (3 ページ)
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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(第27回 1/24)《厚生労働省》 |
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総説、診療ガイドライン
等の名称
Contraceptive
Technology
edition
21th
WHO
Medical
eligibility
criteria
for contraceptive use
5th edition
著者、団体名等
Contraceptive
Technology
World
Health
Organization (WHO)
記載内容(抜粋)
黄体ホルモン
<レボノルゲストレル>
緊急避妊のため性交後 72 時間以内にレボノルゲストレル単剤を服用した 979 例およ
び、レボノルゲストレルとエチニルエストラジオールを服用した 976 例において、結果
として出産に至った婦人の児に関して、児の奇形は報告されなかった。
Emergency Contraception
Effects on future fertility and inadvertently exposed pregnancies.
There is no evidence that ECPs have any long-term or adverse effects on
fertility. One study of 332 pregnant women who had used LNG ECPs in the
conception cycle found no increased risk of birth defects. Combined data from
post-marketing surveillance and clinical trials of UPA found no teratogenic
effects among 232 pregnancies with a known outcome in which the woman and
conceptus were exposed to UPA. Moreover, two observations provide reassurance
for any concern about birth defects. First, in the event of treatment failure,
ECPs are taken long before organogenesis starts so, they should not have a
teratogenic effect. Second, studies that have examines births to individuals
who inadvertently continued to take combined oral contraceptives (including
high-dose formulations) without knowing they were pregnant have found no
increased risk of birth defects. For this reason, the FDA removed warnings
about adverse effects of combined oral contraceptives on the fetus from
contraceptive package inserts years ago.
9. Recommendations for use of emergency contraceptive pills, including adding
the condition of obesity and the new method, ulipristal acetate
Recommendations
For pregnant women, emergency contraceptive pill (ECP) use is not applicable.
Although this method is not indicated for a woman with a known or suspected
pregnancy, there is no known harm to the woman, the course of her pregnancy,
or the fetus if ECPs are accidentally used.
Quality of the evidence
Currently pregnant women
3
等の名称
Contraceptive
Technology
edition
21th
WHO
Medical
eligibility
criteria
for contraceptive use
5th edition
著者、団体名等
Contraceptive
Technology
World
Health
Organization (WHO)
記載内容(抜粋)
黄体ホルモン
<レボノルゲストレル>
緊急避妊のため性交後 72 時間以内にレボノルゲストレル単剤を服用した 979 例およ
び、レボノルゲストレルとエチニルエストラジオールを服用した 976 例において、結果
として出産に至った婦人の児に関して、児の奇形は報告されなかった。
Emergency Contraception
Effects on future fertility and inadvertently exposed pregnancies.
There is no evidence that ECPs have any long-term or adverse effects on
fertility. One study of 332 pregnant women who had used LNG ECPs in the
conception cycle found no increased risk of birth defects. Combined data from
post-marketing surveillance and clinical trials of UPA found no teratogenic
effects among 232 pregnancies with a known outcome in which the woman and
conceptus were exposed to UPA. Moreover, two observations provide reassurance
for any concern about birth defects. First, in the event of treatment failure,
ECPs are taken long before organogenesis starts so, they should not have a
teratogenic effect. Second, studies that have examines births to individuals
who inadvertently continued to take combined oral contraceptives (including
high-dose formulations) without knowing they were pregnant have found no
increased risk of birth defects. For this reason, the FDA removed warnings
about adverse effects of combined oral contraceptives on the fetus from
contraceptive package inserts years ago.
9. Recommendations for use of emergency contraceptive pills, including adding
the condition of obesity and the new method, ulipristal acetate
Recommendations
For pregnant women, emergency contraceptive pill (ECP) use is not applicable.
Although this method is not indicated for a woman with a known or suspected
pregnancy, there is no known harm to the woman, the course of her pregnancy,
or the fetus if ECPs are accidentally used.
Quality of the evidence
Currently pregnant women
3