關於左炔諾孕酮子宮內釋放系統(Levonorgestrel-Releasing Intrauterine System, Mirena®)安全性的最新資訊 Latest safety update on Levonorgestrel-Releasing Intrauterine System(Mirena®)

    拜耳公司(Bayer Inc.)與加拿大衛生部(Health Canada)通知衛生專業人士關於使用左炔諾孕酮子宮內釋放系統(Levonorgestrel-Releasing Intrauterine System, Mirena®)的婦女曾出現子宮穿孔的重要安全性資訊。與使用子宮內避孕裝置有關的子宮穿孔屬罕見及嚴重的不良事件, 發生率介於1/1000至1/10000。為了減低使用Mirena®後發生不良事件的風險, 醫生和其他衛生專業人士必須:

  • 確保本身熟悉和/或曾接受正確放置Mirena®系統的技術, 以及詳細閱讀說明書中的放置指引。
  • 如遇系統難以放置﹑病人感到痛楚或懷疑系統未正確放置的情況下, 可考慮採用超聲波或X光映像。
  • 於放置系統後4至12周, 對病人作檢查, 然後每年再作檢查, 如有需要, 可提高檢查的次數。
  • 於放置系統前, 告知病人子宮穿孔的風險, 尤其在分娩後和哺乳期間所出現的風險, 並教育病人可能出現的症狀, 包括可能與出血有關的嚴重下腹疼痛。

 

        Bayer Inc., in collaboration with Health Canada, would like to remind health professionals of important safety information regarding reports of uterine perforation in women treated with Levonorgestrel-Releasing Intrauterine System(Mirena®). Uterine perforation is a rare, but serious complication associated with intrauterine contraceptive devices, and occurs at a rate between 1/1,000 and 1/10,000 insertions. In order to minimize the risk of complications associated with the use of Mirena®, physicians and other health professionals are encouraged to:

  • Ensure they are familiar with and/or trained on the correct insertion technique for Mirena®, and carefully review the insertion instructions included in the labelling.
  • Consider performing ultrasound or X-ray imaging in case of a difficult insertion, if patients complain of pain, or if there is suspicion that the system may not be correctly positioned.
  • Follow up patients 4 to 12 weeks after insertion, and once a year thereafter of more frequently, as required.
  • Inform patients before the procedure about the risk of uterine perforation, especially in the post-partum period and during lactation, and educate them on possible signs of this complication, including severe low abdominal pain, which may be associated with bleeding.

  

參考資料/Reference and website:

https://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/mirena_hpc-cps-eng.php

https://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2010/mirena_hpc-cps-eng.pdf


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