Poor Neonatal Adaptation After in Utero Exposure to Duloxetine

Abstract

TO THE EDITOR: Risk-benefit analysis is central when forming a treatment plan for pregnant women with mental illness. This task is further complicated by limited data pertaining to the effects of antidepressants on the fetus, neonate, and child. To our knowledge, this is the first case report of in utero exposure to duloxetine. "Ms. A" was a 36-year-old Caucasian female with a history of recurrent major depression, anorexia, and chronic neck pain. When she sought psychiatric consultation at 34 weeks' gestation, she was 1) in complete remission, 2) being treated by an anesthesiologist, 3) and receiving monotherapy duloxetine (90 mg/day). She was educated about neonatal behavioral syndrome, and duloxetine was subsequently decreased to 60 mg/day.The child was delivered without complication at 38 weeks. Upon delivery, she was blue, with minimal respiratory effort and oxygen saturations in the 80s. Her Apgar scores were 7 and 9. After birth, she was transferred to the neonatal intensive care unit because she continued to require oxygen. The child was started on antibiotics while possible causes of transient tachypnea were assessed. Basic laboratory examination, blood gas, echocardiogram, and chest and abdominal x-rays were all normal on day 1. Breast feeding was discouraged because of concerns of exposure to duloxetine, and the mother was advised to switch to sertraline. Antibiotic treatment was discontinued after blood cultures remained negative.On day 3, the child was weaned to room air but developed "jerky rhythmic movements," or "twitchiness." An electroencephalogram (EEG) showed nonspecific encephalopathic findings. The child did have episodes of shaking, and the EEG revealed no correlated changes. Phenobarbital was started, and despite a high blood level the following day, the child continued to experience occasional twitching. Head computed tomography, magnetic resonance imaging, and lumbar puncture were all normal. A repeat EEG conducted at 7 days was suggestive of subclinical seizures. A follow-up EEG at 7 weeks was normal. Phenobarbital was discontinued, and the child was diagnosed with tremors and neonatal seizures associated with neonatal behavior syndrome. At age 2, the child is healthy with consistently normal neurobehavioral development.

Rates of Major Malformations in Infants Following Exposure to Duloxetine During Pregnancy

“…2 Here, we report the results of an international collaboration designed to evaluate the safety of this medication during pregnancy. Our main objective was to determine whether the use of duloxetine during the first trimester of pregnancy is associated with an increased risk for major malformations above the baseline of 1%-3%.…”

Duloxetine Withdrawal Syndrome in a Newborn

“…1 To our knowledge, there has been only one published report suggesting a poor neonatal response after duloxetine exposure in utero. 8 In that case, a full-term infant was born with respiratory distress and was transferred to the NICU for oxygen therapy. On DOL 3, the infant developed jerky movements and was placed on phenobarbital; findings of an electroencephalogram recorded at that time were nonspecific, but phenobarbital therapy was continued until the infant reached 7 weeks of age.…”

The Safety of Duloxetine During Pregnancy and Lactation

“…However, at a 2-year follow-up, the child was healthy with consistently normal neurobehavioral development. 20 Another case of neonatal withdrawal syndrome was described after latepregnancy exposure to duloxetine (90 mg/d) in a woman who was receiving insulin for gestational diabetes; because the woman was also receiving lamotrigine (100 mg/d) and quetiapine (800 mg/d), it is uncertain to what extent duloxetine contributed to the PNAS. 21 Bellantuono et al 22 described a 42-year-old woman with a past history of major depressive illness and comorbid panic disorder who received duloxetine (60 mg/d) throughout pregnancy; she delivered a healthy baby at 37 weeks of gestation.…”