Pharmacovigilance analysis of the Vigibase on neonatal withdrawal syndrome following in utero exposure to antidepressants

Introduction Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitors (SSRIs). Objectives To ascertain whether maternal treatment may be associated with in neonates, investigating the comparative reporting between individual and classes. Methods We performed a case/non-case pharmacovigilance study, searching reports of newborns VigiBase, WHO database suspected adverse drug reactions. Disproportionality analysis was performed, estimating odds ratio (ROR) Bayesian information component (IC). Antidepressants were compared to all medications, methadone, within each class (SSRIs, tricyclics (TCA) antidepressants). ranked terms clinical priority, based semiquantitative score. Results retrieved 406 379 neonates related 15 antidepressants. Compared drugs, disproportionate detected altogether (ROR: 6.18, 95%CI:5.45-7.01), TCAs (10.55, 95%CI:8.02-13.88), 5.90, 95%CI:4.74-7.36) SSRIs 4.68, 95%CI:4.04-5.42). All showed significant disproportionality, apart from bupropion (figure 1). did not find any methadone. The priority ranking moderate antidepressants, exception four, that had weak one Most frequently reported symptoms respiratory (n=106), irritability/agitation (n=75), tremor (n=52) feeding problems (n=40). Image: Conclusions Exposure utero signals most Clinicians should pay extra attention antidepressant-treated mothers. Disclosure Interest C. Gastaldon: None Declared, E. Arzenton : Raschi: O. Spigset: D. Papola: G. Ostuzzi: U. Moretti: Trifirò Grant / Research support from: he scientific director Master program pharmacovigilance, pharmacoepidemiology real-world evidence which has received non-conditional grant various pharmaceutical companies; coordinated team at University Messina until Oct 2020, funding conducting observational studies companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He also coordinator academic spin-off “INSPIRE srl” contract research organizations (RTI Health Solutions, Pharmo Institute N.V.)., Consultant of: served last three years advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, Amgen, Speakers bureau Barbui: Schoretsanitis Dr. as consultant HLS Therapeutics Thermo Fisher Scientific.