From the FDA Drug Label
May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients that third trimester use of brexpiprazole may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy.
Rexulti Safety in Pregnancy:
- The use of Rexulti (brexpiprazole) in pregnancy may cause extrapyramidal and/or withdrawal symptoms in neonates, especially with third trimester exposure.
- Patients with a known or suspected pregnancy should notify their healthcare provider.
- Due to the potential risks, the use of Rexulti in pregnancy should be approached with caution 1, 1.
From the Research
The safety of Rexulti (brexpiprazole) during pregnancy is not well established, and it is generally recommended to avoid Rexulti during pregnancy unless the potential benefits clearly outweigh the risks. Limited human data exists on its use during pregnancy, placing it in a situation where caution is warranted. Animal studies have shown some adverse effects at doses higher than those used in humans, but animal data doesn't always predict human outcomes.
Some key points to consider when evaluating the safety of Rexulti during pregnancy include:
- The potential risks of psychotropic medications need to be balanced against the risks associated with untreated psychiatric conditions and the discontinuation of necessary medications 2.
- Selective serotonin reuptake inhibitors (SSRIs), which are related to Rexulti, have been associated with an increased risk of preterm birth, low birth weight, and congenital malformations 3, 4.
- The importance of serotonin for embryonic development and the effect of serotonin inhibition on the occurrence of malformations should be considered when evaluating the safety of Rexulti during pregnancy 5.
If you're currently taking Rexulti and are pregnant or planning pregnancy, consult with your healthcare provider immediately to discuss your specific situation. They may consider alternative medications with better established safety profiles during pregnancy, especially for conditions like schizophrenia or depression where untreated illness itself poses risks to both mother and developing baby. Never stop taking Rexulti suddenly without medical supervision, as abrupt discontinuation can lead to withdrawal symptoms or worsening of the underlying condition. Your doctor will help weigh the risks of medication against the risks of untreated mental illness during pregnancy to determine the safest approach for your individual circumstances.