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美国FDA药品评价和研究中心提议撤销Makena许可
Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research


Christina Y. Chang ... 妇产科和儿科 • 2020.12.10
相关阅读
• 早产和17OHP——美国FDA为何不应撤销许可

2020年10月5日,美国食品药品管理局(FDA)药品评价和研究中心(CDER)建议撤销Makena(己酸羟孕酮注射液)的许可,即目前批准用于预防复发性早产的唯一药物1。我们在本文中总结了提出上述建议的理由。

美国每年约有10%的新生儿早产(在妊娠37周之前出生)。早产是严重的公共卫生问题,它可增加新生儿死亡、出现并发症和长期后遗症(如永久性神经功能缺损)的风险2。“自发性”早产是一种我们不甚了解的综合征,通常无明显诱因,约占所有病例的3/4。





作者信息

Christina Y. Chang, M.D., M.P.H., Christine P. Nguyen, M.D., Barbara Wesley, M.D., M.P.H., Jia Guo, Ph.D., Laura Lee Johnson, Ph.D., and Hylton V. Joffe, M.D., M.M.Sc.
From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

 

参考文献

1. Food and Drug Administration Center for Drug Evaluation and Research. Makena (hydroxyprogesterone caproate injection) information (https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information. opens in new tab).

2. Centers for Disease Control and Prevention. Reproductive health: preterm birth (https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. opens in new tab).

3. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003;348:2379-2385.

4. Food and Drug Administration. Guidance for industry: expedited programs for serious conditions — drugs and biologics. May 2014 (https://www.fda.gov/media/86377/download. opens in new tab).

5. Food and Drug Administration. Event materials for the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting, October 29, 2019 (https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-29-2019-meeting-bone-reproductive-and-urologic-drugs-advisory-committee-meeting-announcement#event-materials. opens in new tab).

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