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Can you take Rexulti while pregnant?

Whether to take Rexulti during pregnancy involves a thorough consultation with your healthcare provider, who can weigh the risks against the benefits
Wendy Wisner
By | Sep. 24, 2024 Medically reviewed by Leslie Greenberg, MD
A person smiling, holding their belly: Can you take Rexulti while pregnant?

Key takeaways

  • It is not known whether Rexulti is safe to take during pregnancy because no human clinical trials have been done on Rexulti during pregnancy.

  • Other similar antipsychotic drugs have caused serious side effects in babies, including preterm birth and low birth weight.

  • Because of the lack of research on humans and concerns about potential harm to the baby, most healthcare providers don’t recommend Rexulti during pregnancy.

  • You should contact your healthcare provider if you have questions about the use of Rexulti in pregnancy or need additional information about medication use in pregnancy.

In this article:

Rexulti (brexpiprazole) is an atypical antipsychotic medication approved by the Food and Drug Administration (FDA) to treat major depressive disorder (MDD) in adults. It’s also FDA approved to treat schizophrenia in adults and adolescents 13 and older. Rexulti is also approved to treat agitation symptoms associated with dementia due to Alzheimer’s disease.

If you are pregnant or considering getting pregnant, you might want to know if it’s safe to use Rexulti during pregnancy. Here, we’ll take a look at Rexulti and pregnancy, including what the research says, what the potential risks are, whether you can use Rexulti while breastfeeding, and alternatives to Rexulti during pregnancy and lactation.

Can you take Rexulti while pregnant?

Most healthcare providers don’t recommend Rexulti during pregnancy. Unfortunately, the topic of Rexulti and pregnancy isn’t well studied, and the medication could cause problems toward the end of pregnancy that could negatively impact newborns. 

Rexulti’s manufacturer, Otsuka Pharmaceutical Co., Ltd., also advises against taking  Rexulti during pregnancy due to the risk of adverse effects on the baby. Taking Rexulti while pregnant is of particular concern during the third trimester of pregnancy when it has the potential to cause your baby to experience abnormal muscle movements. Withdrawal symptoms after birth are also possible with Rexulti.

According to Rexulti’s drug label, no birth defects were noticed when pregnant rats and rabbits were given Rexulti. But, when administered at 73 times the maximum recommended human dose, there was a decrease in live births, an increase in early postnatal deaths, impaired nursing, and decreased body weight. There was no effect when the pregnant animals were administered 24 times the maximum recommended human dose. 

Ozan Toy, MD, a psychiatrist and chief medical officer at Telapsychiatry, doesn’t recommend pregnant women use Rexulti. “Rexulti is not generally recommended during pregnancy unless the benefits truly outweigh the risks,” he says. “This is mainly because this is a newer medication on the market, and we just don’t have enough data to support its use.”

Sham Singh, MD, a psychiatrist at Winit Clinic, agrees with this advice. Although Rexulti can be helpful in managing psychiatric conditions like MDD and schizophrenia, he doesn’t recommend it to his patients.

“As a psychiatrist, I believe discussing the safety of Rexulti (brexpiprazole) during pregnancy requires careful consideration due to limited research and the complexity of psychiatric medication use in pregnancy,” Dr. Singh says. “There seems to be limited research on the safety of Rexulti during pregnancy, so its effects are not well-established.”

What are the risks of taking Rexulti while pregnant?

Again, there is very little research and no clinical trials on the side effects of Rexulti (brexpiprazole) while pregnant. When there is so little research on a particular drug, most providers don’t recommend it because of potential risks to both mothers and babies.

There are concerns about how Rexulti can impact a growing baby during pregnancy. “Although not much is well understood about Rexulti in pregnancy, it is known to cross the placenta during pregnancy, so this should be considered when prescribing this medication,” Dr. Toy says.

The main concerns with Rexulti are about how it might impact babies during the third trimester of pregnancy and through the immediate postpartum period. These concerns include medical conditions like withdrawal symptoms, respiratory issues, or premature delivery, according to Dr. Toy. “Another possible side effect to a neonate could be experiencing extrapyramidal symptoms, which are basically side effects related to neurological motor function in a fetus.”

Although we don’t have much data on the side effects of Rexulti in particular, we do know that antipsychotic medication, in general, is known to be risky in pregnancy and increase the risk of serious medical conditions. “Generally, antipsychotic medications pose potential risks during pregnancy, including an increased chance of adverse pregnancy outcomes such as preterm birth and low birth weight,” Dr. Singh says.

Still, he notes that untreated mental illness is a pregnancy risk that needs to be strongly considered as well. “Untreated psychiatric illnesses themselves can also have significant risks for both the pregnant individual and the baby,” Dr. Singh emphasizes.

Can you take Rexulti while breastfeeding?

It isn’t advised. “Rexulti is not typically recommended during breastfeeding as it is unknown whether it passes into breast milk,” Dr. Toy says. “There are not enough human studies for psychiatrists to prescribe this medication with confidence during breastfeeding.”

According to LactMed at the National Library of Medicine, there is no available research on the safety of Rexulti (brexpiprazole) during lactation, how it might affect infants, and whether it is excreted into breast milk. There is one case report of a woman who took Rexulti while breastfeeding and experienced a drop in milk supply. However, one case study isn’t enough to conclude that Rexulti causes a low milk supply. Still, because of potential concerns and lack of research, LactMed recommends against the use of Rexulti while breastfeeding and recommends mothers seek alternative treatment medications.

What can I take instead of Rexulti during pregnancy?

Schizophrenia and MDD are serious mental health conditions that benefit from treatment. MDD symptoms include low mood, suicidal thoughts, and an inability to function in day-to-day life. Untreated schizophrenia can cause suicidal thoughts and psychosis. In most cases, over-the-counter supplements and alternative treatments aren’t sufficient to treat MDD and schizophrenia effectively, and prescription medication is necessary.

If you are pregnant and unable to take Rexulti, it’s important that you speak to your mental healthcare provider about alternative medications and mental health treatments. There are some antidepressants and antipsychotic drugs that are known to be safer than Rexulti during pregnancy.

Every individual is unique, and your healthcare provider will find a medication that’s best for you. Dr. Toy says that there are other antipsychotic medications, such as quetiapine, that are better studied and considered safer during pregnancy and, therefore, more often recommended by psychiatrists.

Quetiapine (used to treat schizophrenia, major depression, and bipolar disorder) is sold under the brand name Seroquel. It doesn’t increase the chance of miscarriage or birth defects but might increase the risk of maternal gestational diabetes and low birth weight in the infant.

As with any medication you are considering taking during pregnancy, seeking medical advice and receiving ongoing prenatal care to monitor any possible reactions is vital. “Overall, the decision to use any medication in pregnancy depends on the severity of the mother’s condition and potential risks to the fetus, which is a conversation that needs to take place between physician and their patient,” Dr. Toy concludes.

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