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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
PATIENT PACKAGE INSERT
Mirena is contraindicated when one or more of the following conditions exist:
...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...
...In some cases, severe pain occurred within hours of insertion followed by sepsis within days...
Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later...
...Surgical intervention is not usually required.
...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