Labeling Updated for IUDs Regarding Perforation Risk
The Food and Drug Administration (FDA) has approved updated labeling for intrauterine systems (IUS) regarding an increased risk of perforation in lactating women.
The Prior Approval supplemental New Drug Applications (sNDA) for Bayer's Mirena (levonorgestrel-releasing IUS 52mg) and Skyla (levonorgestrel-releasing IUS 13.5mg) include an update to the Warnings and Precautions section reflecting this risk. The section describes the magnitude of increased risk of uterine perforation if an IUS is inserted when a woman is lactating.
Data from a large, 1-year postmarketing safety study conducted in Europe found that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation.
In general, the warning states that perforation (total or partial, including penetration/embedment of IUS in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation occurs, the IUS should be located and removed; surgery may be required. Risk of perforation may be higher if the IUS is inserted when the uterus is fixed retroverted or not completely involuted.
Corresponding updates have been made to the Patient Counseling to describe this risk. It states that although IUS use is not likely to affect the quality or amount of breast milk or the health of the baby, isolated cases of decreased milk production have been reported among women using progestin-only birth control pills. Further, the risk of the IUS becoming embedded or going through the wall of the uterus is increased if it is inserted while the woman is breastfeeding.
Mirena is indicated to prevent pregnancy for up to 5 years and to treat heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception. Skyla is indicated to prevent pregnancy for up to 3 years.
For more information visit FDA.gov.