Olanzapine-exposed pregnancies and lactation: Early experience

Psychosis frequently occurs in women of childbearing potential who may have unplanned pregnancies. Understanding the risk of prenatal antipsychotic ex posure can be of benefit in selecting therapies, The authors evaluated the in utero and lactation exposure effects of olanzapine, a novel antipsychoti c that is used in treating schizophrenia, bipolar disorder, and other condi tions and that may have expanded use in the childbearing population. All pr ospectively and retrospectively ascertained pregnancy reports were collecte d as a registry in the Lilly Worldwide Pharmacovigilance Safety Database, O utcomes were available from 23 prospectively ascertained olanzapine-exposed pregnancies. Spontaneous abortion occurred in 13%, stillbirth in 5%, major malformation in 0%, and prematurity in 5%, all within the range of normal historic control rates. There were 11 retrospectively ascertained cases of pregnancy, Two retrospectively ascertained cases of lactation exposure did not suggest infant risk, The early experience with olanzapine use in pregna ncy and lactation is encouraging in that no obvious added risk to the fetus or infant was observed. Additional cases of pregnancy and lactation exposu re need to be evaluated to determine whether these early findings are repre sentative of the risks of olanzapine exposure to the fetus and infant. At t his time, olanzapine should only be used during pregnancy and lactation whe n the potential benefit justifies the potential risk to the fetus or infant .