((B-261)) (B-261) Risk of Major Congenital Anomalies in Offspring of Patients Exposed to Treatments for Bipolar Disorder During Pregnancy

Background: Among patients with bipolar disorder, stopping treatment during pregnancy may result in worsening of symptoms, which may be harmful to parent and offspring. Although some studies report a possible association between exposure to antipsychotics during pregnancy and congenital anomalies in offspring, information on the risk of these treatments used during pregnancy is limited.

Objectives: Estimate the risk of major congenital anomalies in offspring of patients exposed to bipolar disorder medications during pregnancy.

Methods:

Design: Cohort study.
Setting: UK Clinical Practice Research Datalink (CPRD) Aurum and GOLD databases and Hospital Episode Statistics Admitted Patient Care (HES) data.
Study population: Female patients with ≥1 diagnosis of bipolar disorder and ≥1 bipolar disorder medication prescription recorded at any time, restricted to patients with estimated last menstrual period (LMP) on or after January 1, 2000, aged 14-45 years at LMP, and at least one year of recorded data before LMP. Analyses will include all eligible pregnancies with linkage to liveborn offspring.
Exposure: Prescription for bipolar disorder medication (aripiprazole, asenapine, carbamazepine, haloperidol, lamotrigine, lithium, lurasodone, olanzapine, quetiapine, risperidone, topiramate, valproate products, ziprasidone), during pregnancy or within three months before LMP.
Outcomes: Major congenital anomalies diagnosed within the first year of life, by body system.
Analyses: We will evaluate exposures by drug class (atypical antipsychotic, mood stabilizer, other) and individual study drug compared to unexposed pregnancies (common referent) using logistic regression and general linear models to calculate relative risks with 95% CI. We will control for calendar time, while other potential confounders (e.g., pre-pregnancy BMI, birthing parent age, smoking status, alcohol and drug abuse, SES, diabetes, insulin use, history of infertility, sex of baby, and premature delivery) will be evaluated for inclusion using regression modeling.

Results: We found 3,509 pregnant patients and 4853 pregnancy episodes in CPRD GOLD and 12,771 pregnant patients and 17,132 pregnancy episodes in CPRD Aurum that meet our study criteria. We found 2,360 linked offspring among CPRD GOLD pregnancy episodes and 7,158 linked offspring among CPRD Aurum pregnancy episodes.

Conclusions: Analyses are underway and will be completed in the coming months. The study results will help clinicians and patients make decisions regarding treatment of bipolar disorder during pregnancy. Supported by a grant from the Gerber Foundation.