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資料２－２ 調査結果報告書 (19 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_24579.html |
| 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3年度第31回 3／22）《厚生労働省》 |
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別添 1
海外添付文書の記載状況（アボネックス）
米国添付文書
4. CONTRAINDICATIONS
（2020 年 3 月版）
（関連記載なし）
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Data from a large population-based cohort study, as well as other published studies over several decades, have not identified
a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings
regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have
been inconsistent (see Data). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted
in an increased rate of abortion at doses greater than those used clinically (see Data).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the
indicated population is unknown.
Data
Human Data
The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an
association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.
In a population-based cohort study conducted in Finland and Sweden, data were collected from 1996--2014 in Finland and
2005--2014 in Sweden on 2,831 pregnancy outcomes from women with MS. 797 pregnancies were in women exposed to
19
海外添付文書の記載状況（アボネックス）
米国添付文書
4. CONTRAINDICATIONS
（2020 年 3 月版）
（関連記載なし）
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Data from a large population-based cohort study, as well as other published studies over several decades, have not identified
a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings
regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have
been inconsistent (see Data). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted
in an increased rate of abortion at doses greater than those used clinically (see Data).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the
indicated population is unknown.
Data
Human Data
The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an
association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.
In a population-based cohort study conducted in Finland and Sweden, data were collected from 1996--2014 in Finland and
2005--2014 in Sweden on 2,831 pregnancy outcomes from women with MS. 797 pregnancies were in women exposed to
19