Label Changes for:

Mirena (Levonorgestrel-Releasing Intrauterine System)

August 2013

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

 

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…
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