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Women of Childbearing Potential David N. Osser, MD Associate Professor of Psychiatry Harvard Medical School Brockton Division of the VA Boston Healthcare System General Editor - Psychopharmacology Algorithm Project Harvard South Shore Residency Training Program

Teratogenicity and Antipsychotics

Teratogenicity and antipsychotic exposure Low teratogenic risk Study limitations Retrospective observational studies Gentile, S. (2010). Antipsychotic therapy during early and late pregnancy. A systematic review. Schizophrenia bulletin, 36(3), 518-544.

Neonatal Complications

Neonatal effects Neonatal dyskinesia Jaundice Some FGAs Weight gain Gestational metabolic syndromes: diabetes macrosomia Some SGAs Increased risk of neonatal seizures Clozapine Low birth weight and high birth weight Hip dysplasia Neural tube defects Olanzapine Neonatal effects Collins, K. O.et al (2003). Maternal haloperidol therapy associated with dyskinesia in a newborn. American journal of health-system pharmacy, 60(21).

Neonatal effects Neonatal dyskinesia Jaundice Some FGAs Weight gain Gestational metabolic syndromes: diabetes macrosomia Some SGAs Increased risk of neonatal seizures Clozapine Low birth weight and high birth weight Hip dysplasia Neural tube defects Olanzapine Neonatal effects Newham, J. J., Tet al (2008). Birth weight of infants after maternal exposure to typical and atypical antipsychotics: prospective comparison study. The British Journal of Psychiatry, 192(5), 333-337  Reis, M., & Källén, B. (2008). Maternal use of antipsychotics in early pregnancy and delivery outcome. Journal of clinical psychopharmacology, 28(3), 279-288.

Neonatal effects Neonatal dyskinesia Jaundice Some FGAs Weight gain Gestational metabolic syndromes: diabetes macrosomia Some SGAs Increased risk of neonatal seizures Clozapine Low birth weight and high birth weight Hip dysplasia Neural tube defects Olanzapine Neonatal effects Ernst, C. L., & Goldberg, J. F. (2002). The reproductive safety profile of mood stabilizers, atypical antipsychotics, and broad-spectrum psychotropics. Journal of Clinical Psychiatry, 63(Suppl 4), 42-55

Neonatal effects Neonatal dyskinesia Jaundice Some FGAs Weight gain Gestational metabolic syndromes: diabetes macrosomia Some SGAs Increased risk of neonatal seizures Clozapine Low birth weight and high birth weight Hip dysplasia Neural tube defects Olanzapine Neonatal effects Spyropoulou, A. C.,et al  (2006). Hip dysplasia following a case of olanzapine exposed pregnancy: a questionable association. Archives of women's mental health, 9(4), 219-222. Arora, M., & Praharaj, S. K. (2006). Meningocele and ankyloblepharon following in utero exposure to olanzapine. European psychiatry, 21(5), 345-346.

Effect of underlying conditions Confounding by indication The problem with observational studies

Recommendations

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

If possible, try to avoid all drugs in the first trimester. If not, try to use the lowest effective dose, and use as few different drugs as possible Adjust doses as pregnancy progresses Blood volume expands 30% in third trimester Plasma level monitoring may be useful Avoid anticholinergics, except for short-term need Avoid depot antipsychotics; infants may show EPS for several months FGAs may be preferred over SGAs in pregnancy This is currently changing

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