Safety

Mirena (Levonorgestrel-Releasing Intrauterine System)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

October 2015

Summary View

WARNINGS AND PRECAUTIONS

Breast Cancer
  • sentence edited...Observational studies of the risk of breast cancer with use of a LNG-releasing IUS do not provide conclusive evidence of increased risk.

ADVERSE REACTIONS

Postmarketing Experience

added bullets...

  • Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke
  • Hypersensitivity (including rash, urticaria and angioedema)
  • Increased blood pressure

 

August 2013

Summary View 

WARNINGS AND PRECAUTIONS

Perforation
  • Clinical trials with Mirena excluded breast-feeding women. An interim analysis from a large postmarketing safety study shows an increased risk of perforation in lactating women…

 

Page Last Updated: 11/13/2015
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