Is Zyprexa (olanzapine) safe to use during pregnancy?

Zyprexa (Olanzapine) Use During Pregnancy

Olanzapine can be used during pregnancy when the benefits of treating severe psychiatric illness outweigh the potential risks, as untreated severe mental disorders pose significant harm to both mother and fetus. 1, 2

FDA Labeling and Regulatory Guidance

The FDA label for Zyprexa explicitly warns that the medication may cause extrapyramidal and/or withdrawal symptoms in neonates when used in the third trimester, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. 1 Pregnant women should be advised to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment. 1

Safety Profile Based on Available Evidence

The most comprehensive safety data comes from a global surveillance review of 610 prospectively identified pregnancies exposed to olanzapine, which found that the frequency of fetal outcomes did not differ from rates reported in the general population. 2

Pregnancy Outcomes:

• Normal births occurred in 66% of pregnancies exposed to olanzapine 2
• Premature births were reported in 9.8% of cases 2
• Perinatal conditions occurred in 8% of pregnancies 2
• No consistent patterns of congenital malformations or organ defects have been identified with olanzapine use 3

Specific Risks to Monitor:

Neonatal withdrawal and adaptation symptoms are the primary concern with third-trimester exposure, manifesting as tremor, jitteriness, irritability, feeding problems, somnolence, and respiratory distress. 1, 4 These symptoms are typically self-limited but require neonatal monitoring. 4

There is emerging evidence suggesting a potential association between antipsychotic use (including olanzapine) and gestational diabetes, warranting glucose monitoring during pregnancy. 3

Clinical Decision-Making Algorithm

When a pregnant woman requires antipsychotic treatment:

1. If already on olanzapine with good symptom control: Continue therapy, as olanzapine is among the most frequently used and studied atypical antipsychotics in pregnancy (along with risperidone and quetiapine). 3

2. If initiating new antipsychotic therapy: Olanzapine is a reasonable choice given its relatively robust safety data compared to other atypicals. 3, 2

3. Monitor throughout pregnancy for:

   • Gestational diabetes (glucose screening) 3
   • Weight gain and metabolic changes 1
   • Maternal psychiatric stability 2

4. Third trimester considerations: Prepare neonatal care team for potential withdrawal symptoms requiring monitoring for respiratory distress, feeding difficulties, tremor, and abnormal muscle tone. 1

Critical Context: Risk of Untreated Illness

The risk of untreated severe psychiatric illness during pregnancy must be weighed against medication risks. Untreated psychotic disorders and severe mood disorders can compromise fetoplacental integrity, fetal central nervous system development, and lead to poor prenatal care, substance abuse, and maternal harm. 5 Given the potential harm of not treating severe psychiatric illnesses during pregnancy, careful administration of antipsychotics is recommended for pregnant women with severe mental disorders. 3

Common Pitfalls to Avoid

Do not discontinue olanzapine abruptly in a pregnant woman with well-controlled psychosis or bipolar disorder, as relapse poses significant risks including poor prenatal care, impaired judgment, and potential harm to mother and fetus. 5, 3

Do not assume all antipsychotics have equivalent safety profiles—olanzapine has more prospective pregnancy data than many alternatives. 2

Do not fail to coordinate care with obstetrics and neonatology teams to ensure appropriate monitoring and neonatal care planning. 1