![]() ![]() In December 2012, she conceived a third time but due to persistent psychiatric symptoms, olanzapine was continued throughout the pregnancy by the treating psychiatrist, who considered there to be a favorable benefit:risk ratio for the patient at that time. This child is presently healthy.Įight months after delivery of this baby the patient had a recurrence of psychotic symptoms for which she was prescribed the same treatment. In 2009, she conceived again (it is noteworthy that the patient was not taking olanzapine during this pregnancy) and delivered a full-term healthy female child in January 2010. A careful history/enquiry from the parents failed to reveal any data available regarding congenital malformation of the aborted fetus. In December 2008, she had a miscarriage at 4 months’ gestation, following which she stopped taking the medication of her own choice. After initial management of acute symptoms there, she continued her treatment from our institute, where she was prescribed olanzapine (Oleanz® 10 mg tablet orally once daily). Following initial unsuccessful local treatment, she was taken to the psychiatry department of a tertiary care hospital. One week after her marriage in February 2008, the patient developed psychotic symptoms such as excessive talking, episodes of crying and laughing, and forgetting things frequently. We report the case of a 29-year-old married woman with bipolar disorder with mixed episodes who had been treated with olanzapine in the psychiatric outpatient department of our institute (Lady Hardinge Medical College, New Delhi, India) for the last 7 years who delivered a full-term female baby with TEF in September 2013. In this case report, we report the first case of tracheo-esophageal fistula (TEF) as a possible teratogenic effect of olanzapine exposure. Given this perspective, the possibility of further teratogenic effects of olanzapine cannot be ruled out. A literature search revealed that maternal exposure to olanzapine appears to be associated with lumbar meningomyelocele, dysplastic kidney, hip dysplasia, atrioventricular canal defect, club foot, microcephaly, ventricular septal defect, absent fingers, craniosynostosis, cleft lip, encephalocele, aqueductal stenosis, etc. Olanzapine, a second-generation antipsychotic, is a US Food and Drug Administration (FDA) pregnancy category C drug with no unequivocal evidence of harm to the fetus. There have been reports of congenital anomalies in newborns of mothers exposed to antipsychotic medications during pregnancy. ![]() Due to ethical issues, pregnant women are rarely included in clinical trials, leading to a dearth of data available on the safety of antipsychotic drugs in this population. Women with psychiatric diseases may become pregnant and are treated with antipsychotics without any proven evidence of safety. ![]() Greater knowledge of this potential teratogenicity caused by olanzapine is needed to reduce morbidity and mortality in newborns. Causality between antenatal maternal olanzapine exposure and TEF in the newborn was determined to be ‘probable’ (score +5) as per the Naranjo causality assessment scale. Unfortunately, however, the baby did not survive beyond 11 months of age. The baby was managed surgically and discharged with satisfactory vital signs. The outcome of the third pregnancy was a full-term female baby with a TEF. However, due to the recurrence of psychiatric illness after her second pregnancy, she was prescribed olanzapine again, which was continued throughout her third pregnancy. She reconceived after a few months and delivered a full-term normal child. Her first pregnancy, while taking olanzapine, resulted in a miscarriage at 4 months’ gestation, following which she discontinued olanzapine. A 29-year-old woman with acute psychotic disorder had been treated with olanzapine for the last 7 years. Against this backdrop, we report the first case of a tracheo-esophageal fistula (TEF) in a newborn following maternal antenatal exposure to olanzapine. Olanzapine, a pregnancy category C drug, has no unequivocal evidence of harm to the fetus. There is a dearth of evidence on the safety of the use of antipsychotics during pregnancy. ![]()
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