Can you take Rexulti while breastfeeding?

In this article:

• Can you take Rexulti while breastfeeding?
• What are the risks of taking Rexulti while breastfeeding?
• What can I take instead of Rexulti while breastfeeding?

In this article

• Can you take Rexulti while breastfeeding?
• What are the risks of taking Rexulti while breastfeeding?
• What can I take instead of Rexulti while breastfeeding?

Rexulti (brexpiprazole) is an atypical antipsychotic approved by the Food and Drug Administration (FDA) to treat major depressive disorder (MDD) in adults on antidepressants and schizophrenia in adults and children 13 years of age and older. It was also recently approved to treat agitation associated with dementia due to Alzheimer’s disease. Rexulti was designed to adjust dopamine and serotonin levels in the brain, although the exact way it works is unknown. 

If you’re pregnant or postpartum and have been prescribed Rexulti, you might wonder: Is it safe to breastfeed on Rexulti? The answer is complicated because there isn’t a lot of research on Rexulti and breastfeeding. Below, we’ll look at what the limited research shows, what the risks of taking Rexulti while breastfeeding might be, and alternative medications to talk to your healthcare provider about.

Can you take Rexulti while breastfeeding?

The Food & Drug Administration recommends the decision to take Rexulti while breastfeeding be made on a case-by-case basis. Rexulti’s manufacturer, Otsuka Pharmaceutical, Inc., also advises talking to your healthcare provider about the best way to feed your baby while taking the medication. Together, breastfeeding parents and their healthcare providers can consider the health benefits of breastfeeding versus the potential negative side effects of Rexulti for the baby, along with the parent’s need to remain on their prescription medication for their mental health.

Still, this is a difficult question, even for healthcare providers. “When it comes to breastfeeding, there is limited data on Rexulti’s safety,” says Sue Ojageer, Pharm.D., founder of Pharmacy Mentors and a SingleCare Best of the Best Pharmacy Awards winner. Kecia Gaither, MD, a double board-certified OB-GYN, agrees, saying there is a lack of information on Rexulti use while breastfeeding. 

Here’s what we do know:

• Brexiprarazole might have the potential to suppress milk supply. Dr. Gaither points to a single case report of “decreased lactation” while taking Rexulti. In this instance, a postpartum woman on Rexulti who reported “ample production” while breastfeeding previous children experienced low milk production. Within 10 days of discontinuing Rexulti, her milk supply increased enough to almost exclusively breastfeed her newborn.
• Brexiprarazole might be linked to lactation disorder. A recent safety assessment report found that out of 8,559 adverse drug event reports related to brexpiprazole, 10 included breast discharge and six included lactation disorder. However, this is a tiny percentage, and controlled clinical trials are needed to determine if these side effects were caused by the drug or some other factor concurrent with Rexulti use.
• Brexiprarazole can pass into breast milk. One case report of a postpartum woman on Rexulti and her baby showed that the infant dose of brexpiprazole was less than 1.1% when passed from the mother to the baby through breast milk. This led the authors to determine that breastfeeding was “still possible” because the dose passed on to the infant was “much less than 10%.” Still, one case study is insufficient to inform clinical guidelines, and the report did not mention how the drug’s presence affected the infant, if at all.
• Brexiprarazole use has not been studied in infants. This drug is approved for patients 13 years and older. “Because the potential effects on a breastfeeding infant are unknown, many healthcare providers may advise caution or recommend against using Rexulti while breastfeeding,” Dr. Ojageer says.
• Side effects have been reported from infant exposure to atypical antipsychotics. A small study of 28 breastfeeding women admitted to the inpatient psychiatric unit of a hospital found that some of the infants exhibited signs of sedation, constipation, and developmental delays. However, these side effects might have been related to other maternal or infant risk factors rather than antipsychotic use. 

Ultimately, there is not enough data to confirm that maternal Rexulti use is definitely safe for a breastfed infant. Since the risk to the infant cannot be ruled out, experts emphasize the importance of a thorough discussion between the patient and healthcare provider about the benefits versus risks of continuing the medication. “If the medication is essential for the mother’s mental health and other options are not suitable, careful monitoring of the infant for signs of side effects such as sedation, feeding difficulties, or developmental issues is recommended,” Dr. Ojageer says.

What are the risks of taking Rexulti while breastfeeding?

Due to limited data, the risk of taking Rexulti during breastfeeding is unknown. The drug may be present in breast milk, but the amount passed on to a breastfeeding baby is small and may or may not cause side effects. There isn’t enough information to confirm one way or the other. 

Likewise, the potential risk of a decreased milk supply or lactation disorder is not defined. Case reports provide helpful information to healthcare providers, but more research is needed. A case report states what happened, not why it happened. The authors did not investigate whether the lactation disorder might have been caused by a different medication or one of the mother’s underlying conditions.

Breastfeeding does not raise the risk of Rexulti side effects, but serious side effects could impact your ability to take care of your baby. Less serious side effects include sleepiness, irritability, and weight gain. Serious side effects include suicidal thoughts, increased cholesterol and triglyceride levels, high blood sugar, neuroleptic malignant syndrome, tardive dyskinesia, low white blood cell count, trouble regulating body temperature, and allergic reactions.

“In addition to having a maternal healthcare provider, postpartum patients on antipsychotic drugs should be under the care of a mental health provider,” Dr. Gaither says. Medication use or discontinuation should be determined on “a case-by-case basis,” she adds.

What can I take instead of Rexulti while breastfeeding?

It’s essential that postpartum parents living with schizophrenia or major depression receive treatment. Left untreated, these medical conditions can increase the risk of side effects such as suicidal thoughts and psychosis. Consequently, maternal and infant health are at risk. 

Rexulti is not the only FDA-approved drug for schizophrenia or major depression. Other antipsychotic agents have been studied more extensively and are considered generally safer for breastfeeding mothers, according to Dr. Ojageer. 

Rexulti alternatives to discuss with your healthcare provider include:

• Zyprexa (olanzapine): “This drug has relatively more data supporting its safety during breastfeeding,” Dr. Ojageer says. “While small amounts are excreted into breast milk, the risk to infants appears to be minimal.”
• Seroquel (quetiapine): This antipsychotic is “excreted in low amounts in breast milk and is considered safer for breastfeeding. It is often recommended when antipsychotic treatment is necessary during breastfeeding,” Dr. Ojageer says.
• Abilify (aripiprazole): While data is limited, Dr. Ojageer says it is considered to have a lower risk profile compared to other antipsychotics like Rexulti.

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In any case of maternal mental health disorders, it is crucial to weigh the benefits of treatment against the potential risks to the baby. Never discontinue an antipsychotic medication without consulting your healthcare team, as withdrawal symptoms may occur. Choosing which treatment to use while breastfeeding should involve a thorough discussion between a patient and her healthcare provider.