1. Prescribing SGAs During Pregnancy
Flavio Guzmán, MD

2. Overview Risks of congenital malformations
Risks of neonatal effects and developmental abnormalities
Treatment recommendations: monitoring

3. Teratogenicity risks

4. Risk of congenital malformations
Relative comfort in prescribing APs
Absence of negative data
Studies haven’t described major congenital malformations associated with SGAs
Snellen, M., & Malhi, G. S. (2014). Bipolar Disorder, Psychopharmacology, and Pregnancy. In Psychopharmacology and Pregnancy (pp ). Springer Berlin

5. Risk of congenital malformations
National Pregnancy Registry for Atypical Antipsychotics
Cohen, L. S., et al (2015). Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. American Journal of Psychiatry, 173(3),

6. Risk of congenital malformations
Primary aim: quantify the risk for congenital malformations
Modeled after North American AED Registry
Based in the Massachusetts General Hospital, Boston
National Pregnancy Registry for Atypical Antipsychotics
Cohen, L. S., et al (2015). Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. American Journal of Psychiatry, 173(3),

7. Risk of congenital malformations
No substantial increase in risk of major malformations
Use of a SGA during first trimester
National Pregnancy Registry for Atypical Antipsychotics
Cohen, L. S., et al (2015). Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. American Journal of Psychiatry, 173(3),

8. Risk of congenital malformations
SGA
Substantial morbidity
Maintain current AP
National Pregnancy Registry for Atypical Antipsychotics
Good response to SGA
Cohen, L. S., et al (2015). Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. American Journal of Psychiatry, 173(3),

9. Neonatal effects

10. Neonatal effects FDA labeling (changed in 2011) Extrapyramidal signs
“Withdrawal symptoms”
Sedation
Agitation
Changes in muscle tone
Breathing and feeding difficulties
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns

11. Maternal weight and neonatal effects
Effect on maternal weight
SGAs may increase maternal weight
Population based cohort study
Increased risk of gestational diabetes
Bodén, R., Lundgren, M., Brandt, L., Reutfors, J., & Kieler, H. (2012). Antipsychotics during pregnancy: relation to fetal and maternal metabolic effects. Archives of general psychiatry, 69(7),

12. Maternal weight and neonatal effects
Higher incidence of large-for-gestational-age deliveries
SGAs: 20%
FGAs: 2%
Other reports: higher weight with antenatal olanzapine exposure
Large for Gestational Age (LGA)
Newham, J. J.et al (2008). Birth weight of infants after maternal exposure to typical and atypical antipsychotics: prospective comparison study. The British Journal of Psychiatry, 192(5),
Babu, G. N., et al (2010). Birth weight and use of olanzapine in pregnancy: a prospective comparative study. Journal of clinical psychopharmacology, 30(3),

13. Neurodevelopmental effects

14. Neurodevelopmental effects
Developmental delays
Present at 6 months
At 12 months there were no differences
Women in the exposed group were:
More likely to be overweight
Less likely to take vitamins
Peng, M., Gao, K. et al (2013). Effects of prenatal exposure to atypical antipsychotics on postnatal development and growth of infants: a case-controlled, prospective study. Psychopharmacology, 228(4),

15. Recommendations

16. Recommendations Ultrasound of fetal size in late pregnancy
Monitor glucose levels
Chisolm, M. S., & Payne, J. L. (2016). Management of psychotropic drugs during pregnancy. BMJ, 352, h5918.

17. End of presentation