Invega Sustenna (Paliperidone) During Pregnancy
Invega Sustenna can be used during pregnancy when the severity of the mother's psychiatric illness requires continued antipsychotic treatment, as the decision should prioritize maternal mental health stability and the clinical context over theoretical fetal risks. 1
Framework for Decision-Making
The American College of Obstetricians and Gynecologists establishes that antipsychotic use during pregnancy must be based on clinical context, individual medication risks, and gestational age 1. In emergencies or severe illness, medications should not be withheld from the mother even if not formally recommended during pregnancy 1.
Safety Evidence for Paliperidone
Available Human Data
No major congenital malformations have been reported in the limited human pregnancy data available for paliperidone 2, 3.
A German Embryotox database analysis of 17 prospectively assessed pregnancies with paliperidone exposure found 15 live-born children with no major congenital malformations 3.
One case report documented safe use of paliperidone palmitate (Invega Sustenna) throughout an entire gestation period in a patient with schizoaffective disorder, with no malformations or perinatal complications 2.
Important Caveats
Prematurity and small-for-gestational-age infants occurred more frequently in the German database study, but this was confounded by high rates of cigarette smoking (65%) and alcohol use (17%) among the pregnant women 3.
The overall evidence base remains limited, with no large, well-designed prospective comparative studies available 4.
To date, no definitive association has been found between antipsychotic use during pregnancy and increased risk of birth defects 4.
Clinical Algorithm
When antipsychotic treatment is needed:
Assess disease severity: If the mother has severe schizophrenia or schizoaffective disorder that would interfere with activities of daily living or infant care if untreated, continuing medication is justified 4.
Consider medication history: If the patient is already stable on Invega Sustenna, switching to another antipsychotic with marginally more data introduces the risk of relapse, which poses greater danger to both mother and fetus 1.
Implement close monitoring: Psychiatric and obstetric monitoring throughout pregnancy is essential, with additional medical and social support 3.
Address modifiable risk factors: Counsel strongly against smoking and alcohol use, as these likely contributed to adverse outcomes in available studies 3.
Common Pitfalls to Avoid
Do not automatically discontinue at 32 weeks gestation based on theoretical concerns about the fetal immune system—this practice is not supported by current data 5.
Do not withhold necessary treatment due to lack of extensive safety data when maternal psychiatric stability is at stake 1.
Do not fail to provide adequate counseling about the balance of risks between untreated maternal illness versus medication exposure 4, 6.
Risk-Benefit Balance
The benefit of treating severe maternal psychiatric illness with Invega Sustenna generally outweighs theoretical risks to the fetus, particularly when the alternative is maternal decompensation that could lead to poor prenatal care, substance use, self-harm, or inability to care for the infant postpartum 1, 4.