Last Updated :2025/11/23

black box warning

Noun
US
Japanese Meaning
処方薬に附され、深刻あるいは生命を脅かす副作用の可能性があることを示すために、黒い枠で囲まれた警告表示。 / 米国において使用される、薬の安全性に関する最も厳しい警告の形式。
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FDAは重篤な心臓障害の報告を受け、その医薬品の添付文書に重篤または生命を脅かす可能性があることを示す黒枠の警告を義務付けた。

plural

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(US) A warning, surrounded by a black border, affixed to a prescription drug to indicate that it may cause serious or life-threatening effects.

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black box warning

The FDA required a black box warning on the medication after reports of severe cardiac events.

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The FDA required a black box warning on the medication after reports of severe cardiac events.

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