処方薬の新ブラックボックス警告と撤回のタイミング
Karen E Lasser1, Paul D Allen, Steffie J Woolhandler
1Department of Medicine, Cambridge Hospital, Cambridge, MA 02139, USA. klasser@challiance.org
JAMA
|May 1, 2002
まとめ
新薬が承認された後,重篤な副作用 (ADR) が発症することが多く,その10.2%がブラックボックス警告または市場撤回を受けた. 薬物の安全性の問題を時間とともに特定するために,市販後の監視は非常に重要です.
科学分野:
- 医薬品監視 医薬品監視
- 薬物安全 薬物安全
- 規制科学 規制科学とは
背景:
- 新しく承認された薬剤には,未知の副作用 (ADR) が潜んでいる可能性があります.
- マーケティング後の監視で特定された重要なADRの頻度に関する最近の研究は限られている.
研究 の 目的:
- 薬の承認後に新しいADRが発見される頻度を決定する.
- これらの発見のタイミングを評価し,特にブラックボックス警告や市場撤退に焦点を当てます.
主な方法:
- 1975年から1999年の間に米国食品医薬品局 (FDA) によって承認された新しい化学物質の分析.
- ブラックボックス警告または離脱事件のために,1975年から2000年の間に市場から撤回された薬物のレビュー.
主要な成果:
- 新薬の10.2% (548件中56件) はブラックボックス警告または撤回を受けた.
- 薬物の2.9%が禁用され,8.2%がブラックボックス警告を受けた.
- メジャーラベリングの変更または撤廃の半分は,薬物の導入から7年以内に発生し,撤廃の半分は2年以内に発生しました.
結論:
- FDAの承認後,多くの場合,重大な副作用が現れます.
- 新薬の長期的な安全性プロファイルは,市場での長期間の使用後にのみ明らかになります.
関連する概念動画
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