This sheet is about exposure to lurasidone in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is lurasidone?
Lurasidone is an antipsychotic medication that has been used to treat schizophrenia and bipolar depression. It is sold under the brand name Latuda®.
Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
I take lurasidone. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if lurasidone can make it harder to get pregnant.
Does taking lurasidone increase the chance for miscarriage?
Miscarriage can occur in any pregnancy. Studies have not been done to see if lurasidone can increase the chance for miscarriage.
Does taking lurasidone increase the chance of birth defects?*
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Information on the use of lurasidone in pregnancy is limited. Animal studies in rats and rabbits have not shown an increased chance of birth defects. In a case report of a person taking lurasidone throughout pregnancy, the baby was born healthy and without birth defects. A study looking at 134 people who used lurasidone in pregnancy found no specific patterns of birth defects.
Does taking lurasidone in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if lurasidone use in pregnancy increases the chance for pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).
I need to take lurasidone throughout my entire pregnancy. Will it cause symptoms in my baby after birth?
Product labels written by the U.S. Food and Drug Administration (FDA) note a chance for symptoms in newborns exposed to antipsychotic drugs in the third trimester of pregnancy. Symptoms may include uncontrolled muscle movements, changes in muscle tone, being too sleepy, trouble with breathing, and/or trouble with feeding. Not all babies who are exposed to antipsychotic drugs during pregnancy will have these symptoms. These symptoms can be temporary and can go away on their own. Treatment of symptoms can be started, if needed.
These symptoms have not been reported with exposure to lurasidone during pregnancy. The available information on the use of lurasidone in pregnancy is so limited that it is hard to know if these symptoms might happen. Let your healthcare providers know before delivery if you are taking lurasidone. If needed, babies can be monitored for symptoms.
Does taking lurasidone in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if lurasidone use in pregnancy can cause behavior or learning issues for the child.
Breastfeeding while taking lurasidone:
Information on the use of lurasidone while breastfeeding is limited. There is a report of one person who was taking lurasidone while breastfeeding. No negative effects were reported in the nursing child. The benefit of using lurasidone may outweigh possible risks. Your healthcare providers can talk with you about using lurasidone and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes lurasidone, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done in humans to see if lurasidone could affect fertility or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/
A pregnancy registry for psychiatric medications, including lurasidone, has been organized at the Massachusetts General Hospital. For more information, contact the registry at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.