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U.S. Department of Health and Human Services

Safety

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Mirena (levonorgestrel-releasing intrauterine system)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS

  • Ectopic Pregnancy
  • Sepsis
  • Perforation
  • Ovarian Cysts
  • Breast Cancer

PRECAUTIONS

  • Continuation and Removal
    • Mirena should be removed for the following reasons:
      • Pelvic Infection
      • Endometritis
  • Drug Interactions
  • Nursing Mothers

ADVERSE REACTIONS

  • Other relevant reported adverse reactions occurring in less than 5% of subjects include:
    • Vomiting
  • Postmarketing Experience

PATIENT PACKAGE INSERT

  • What is Mirena?
  • How does Mirena work?
  • Who should not use Mirena?
  • Tell your health care provider if you...
  • How is Mirena placed?
  • How can I check that Mirena is in place?
  • Is it safe to breast-feed while using Mirena?
  • What are the possible side effects of usine Mirena?
  • When should I call my health care provider?

CONTRAINDICATIONS

Mirena is contraindicated when one or more of the following conditions exist:

  • Conditions associated with increased susceptibility to pelvic infections.

WARNINGS

Ectopic Pregnancy

...Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.

Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy...

Sepsis

...In some cases, severe pain occurred within hours of insertion followed by sepsis within days...

Perforation

Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later...

Ovarian Cysts

...Surgical intervention is not usually required.

Breast Cancer

...Two observational studies have not provided evidence of an increased risk of breast cancer during the use of Mirena.

 

Label approved 05/28/2008 is not available on Drugs@FDA