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Label Changes for:

Skyla (levonorgestrel-releasing intrauterine system)

April 2016

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

April 2016


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


Post-Marketing Experience
  • …Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke…


September 2013


Should I check that Skyla is in place?

  • Yes, you should check that Skyla is in proper position by feeling the removal threads. It is a good habit to do this once a month. Your healthcare provider should tell you how to check that Skyla is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the removal threads. Do not pull on the threads. If you feel more than just the threads or if you cannot feel the threads, Skyla is not in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide) and ask your healthcare provider to check that Skyla is still in the right place. 


August 2013


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