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50% of mothers breastfeed for >2 months3
- Clinical trials with Mirena excluded breast-feeding women. An interim analysis from a large post marketing safety study shows an increased risk of perforation in lactating women
- Tell your breastfeeding patients that although small amounts of progestins pass into the breast milk of nursing mothers, Mirena is not likely to affect quality or amount of their breast milk or the health of their nursing babies
Consider the following when you talk with her about Mirena
Mirena should not be inserted until 6 weeks postpartum or until involution of the uterus is complete due to the increased risk of perforation and expulsion. If involution is substantially delayed, consider waiting until 12 weeks postpartum. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.
The use of Mirena is contraindicated in women with postpartum endometritis or infected abortion in the past 3 months.
Know who is appropriate for Mirena
Mirena (levonorgestrel-releasing intrauterine system) is indicated for intrauterine contraception for up to 5 years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena is recommended for women who have had a child.
Know who is not appropriate for Mirena
Mirena is contraindicated in women with known or suspected: pregnancy; congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; breast carcinoma; uterine or cervical neoplasia; unresolved, abnormal Pap smear; liver disease including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in past 3 months; unexplained vaginal bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); or conditions increasing susceptibility to pelvic infections.
Use with caution in patients with certain conditions
In patients with certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts, Mirena increases risk of infective endocarditis and may be a source of septic emboli. Give appropriate antibiotics at insertion and removal to patients with known congenital heart disease who may have higher risk. Monitor for infections any patient on chronic corticosteroid therapy or insulin for diabetes.
Use Mirena with caution in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction.
In the event of pregnancy
If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation may result in pregnancy loss. Up to half the pregnancies that occur with Mirena in place are ectopic. Tell women about the risks of ectopic pregnancy including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy.
Educate her about PID
Prior to insertion, inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted diseases (STDs); Mirena does not protect against STDs, including HIV. The highest risk of PID occurs shortly after insertion (usually within the first 20 days).
Expect changes in bleeding patterns
Expect spotting and irregular/heavy bleeding for 3-6 months, then shorter, lighter periods. Cycles may remain irregular and become infrequent and may cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUDs like Mirena are expulsion, sepsis, myometrial embedment and uterine or cervical perforation. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.
Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian follicles.
The most common adverse reactions (>10%) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4-12 weeks after insertion and then yearly or more often if clinically indicated.
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
For important risk and use information, please see the Full Prescribing Information.
References:
- Centers for Disease Control and Prevention. National Center for Health Statistics. Data Access Web site.
http://www.cdc.gov/nchs/data_access/ftp_dua.htm?url_redirect=ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/
Datasets/NSFG. Accessed July 8, 2011. - Data on file. Consumer profiles. Bayer HealthCare Pharmaceuticals Inc.
- Centers for Disease Control and Prevention. Infant feeding practices study II. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/ifps/results/ch3/table3-36.htm. Accessed July 8, 2011.
