The Food and Drug Administration (FDA) has approved updates to the safety label for the intrauterine device Mirena to include new risks regarding pregnancy or suspected pregnancy.
Mirena is a contraceptive device made by Bayer to prevent pregnancy for up to five years. It is also used to treat heavy menstrual cycles. Mirena is a T-shaped device that is inserted into the cervix where it releases a small amount of the hormone levonorgestrel. The birth control has been linked to risks such as migration of the device, perforation of organs and tissue damage, a well as a ectopic pregnancy.
The update states that the birth control is contraindicated in women who are pregnant or women who are suspected to be pregnant. “Mirena may cause adverse pregnancy outcomes,” if inserted in a pregnant woman or if a woman becomes pregnant with a Mirena IUD, the new labeling states.
“If a woman becomes pregnant with Mirena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery,” the labeling states.
Doctors are advised to remove Mirena, if possible, if pregnancy occurs in a woman using the device. “If Mirena cannot be removed, follow the pregnancy closely.”
The label was also updated to inform women and their doctors that levonorgestrel from the Mirena IUD can show up in breast milk, exposing infants to the hormone. “Isolated cases of decreased milk production have been reported with Mirena,” the new subsection states. “The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mirena and any potential adverse effects on the breastfed child from Mirena or from the underlying maternal condition.”
Source: FDA Safety Label Changes