This document summarizes a review by the FDA's Office of Drug Safety of reports of neonatal withdrawal syndrome associated with in utero exposure to serotonin reuptake inhibitors (SRIs). The review found reports in the FDA Adverse Event Reporting System of withdrawal symptoms in newborns exposed to SRIs late in pregnancy, including citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine. Symptoms included excitatory nervous and neuromuscular events like tremors, hypertonia, and respiratory issues. The symptoms generally began within days of birth and resolved within weeks with supportive care like hospitalization and medication. The review concludes SRIs can cause withdrawal in
1. Neonatal withdrawal syndrome with Serotonin Reuptake Inhibitors Office of Drug Safety Review Kathleen Phelan, R.Ph., Safety Evaluator Division of Drug Risk Evaluation Office of Drug Safety
14. Adverse event information (N=57) 4-16 days 35 26 21 15 5-11 T1/2 hours 1 week (3) 1.5 days (4) Fluoxetine 7 days (5) 12 hours (5) Citalopram 1 day (7) 21 hours (6) Sertraline 1.5-2 wks (17) 18 hours (19) Paroxetine 5 days (1) hours-2 days (2) Fluvoxamine 2 days (1) 10 hours (1) Venlafaxine Median duration (N) Median time to onset (N) Drug
20. Neonatal withdrawal syndrome with Serotonin Reuptake Inhibitors Office of Drug Safety Review Kathleen Phelan, R.Ph., Safety Evaluator Division of Drug Risk Evaluation Office of Drug Safety
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