Label Changes for:

Mirena (levonorgestrel-releasing intrauterine system)

July 2008

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


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

WARNINGS

  • Intrauterine Pregnancy
    • Long-term effects and congenital anomalies
  • Embedment
  • Perforation
  • Expulsion
  • Ovarian Cysts
  • Breast Cancer

PRECAUTIONS

  • Patient Counseling Information
  • Patient Evaluation and Clinical Considerations
    • A physical examination should include...
    • Irregular bleeding may mask symptoms and signs of endometrial polys or cancer...
    • ...If involution is substantially delayed, consider waiting 12 weeks postpartum...
    • Mirena should be used with caution in patients who have:
      • migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
      • exceptionally severe headache
      • marked increase of blood pressure
      • severe arterial disease such as stroke or myocardial infarction
  • Insertion Precautions
    • Observe strict asepsis during insertion...
    • Fundal positioning of Mirena is important to prevent expulsion...
    • If the patient develops decreased pulse, perspiration, or pallor, have her remain supine until these signs resolve. Insertion may be associated with some pain and/or bleeding...
  • Continuation and Removal
    • Re-examine and evaluate patients 4 to 12 weeks after insertion and once a year thereafter...
    • If the threads are not visible, they may have retracted into the uterus or broken, or Mirena may have broken...
    • Promptly examine users with complaints of pain, odorous discharge...
    • Consider the possibility of ectopic pregnancy...
    • Removal may be associated with pain and/or bleeding or neurovascular episodes.

ADVERSE REACTIONS

  • ...Very common adverse reactions (>1/10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts...

PATIENT PACKAGE INSERT

  • Who should not use Mirena?
    • Do not use Mirena if you...
    • have or suspect you might have cancer of the uterus or cervix
    • have breast cancer now or in the past or suspect you have breast cancer
  • Tell your healthcare provider if you
    • have high blood pressure
  • How is Mirena placed?
  • Should I check that Mirena is in the proper position?
  • How soon after placement of Mirena should I return to my healthcare provider?
  • What are the possible side effects of using Mirena?
    • The following are serious but uncommon side effects of Mirena:
      • Embedment...
      • Perforation...
    • Common side effects of Mirena include:
      • Discomfort during placement...
      • Cyst on the ovary...
    • ...You may report side effects to...

PATIENT CHECKLIST (updated)

  • Do you have any of these conditions (the following conditions have been added):
    • Severe headache
    • Stroke
    • High blood pressure

WARNINGS

Intrauterine Pregnancy

If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation of Mirena may result in pregnancy loss...

Long-term effects and congenital anomalies

...Some observational data support a small increased risk of masculinization of the external genitalia of the female fetus following exposure to progestins at doses greater than those currently used for oral contraception. Whether these data apply to Mirena is unknown.

Embedment

...Embedment may decrease contraceptive effectiveness and result in pregnancy (see WARNINGS, Ectopic Pregnancy and Intrauterine Pregnancy). An embedded Mirena should be removed. Embedment can result in difficult removal and, in some cases surgical removal may be necessary.

Perforation

...If perforation occurs, pregnancy may result (see WARNINGS, Ectopic Pregnancy and Intrauterine Pregnancy). Mirena must be located and removed; surgery may be required. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions...

The risk of perforation may be increased in lactating women, in women with fixed retroverted uteri, and during the postpartum period. To decrease the risk of perforation postpartum, Mirena insertion should be delayed a minimum of 6 weeks after delivery or until uterine involution is complete. If involution is substantially delayed, consider waiting until 12 weeks postpartum...

Expulsion

Partial or complete expulsion of Mirena may occur (see PRECAUTIONS, Continuation and Removal). Symptoms of the partial or complete expulsion of any lUD may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it. Partial expulsion may decrease the effectiveness of Mirena. As menstrual flow typically decreases after the first 3 to 6 months of Mirena use, an increase of menstrual flow may be indicative of an expulsion. If expulsion has occurred, Mirena may be replaced within 7 days of a menstrual period after pregnancy has been ruled out.

Ovarian Cysts

...Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases the enlarged follicles disappear spontaneously during two to three months observation. Persistent enlarged follicles should be evaluated...

Breast Cancer

Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception because breast cancer is a hormone sensitive tumor...

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