| アブストラクト | BACKGROUND: Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitor (SSRIs). METHODS: In our case/non-case pharmacovigilance study, based on VigiBase((R)), the WHO database of suspected adverse drug reactions, we estimated reporting odds ratio (ROR) and the Bayesian information component (IC) with 95% confidence/credibility intervals (CI) as measures of disproportionate reporting of antidepressant-related neonatal withdrawal syndrome. Antidepressants were first compared to all other medications, then to methadone, and finally within each class of antidepressants: SSRIs, tricyclics (TCA) and other antidepressants. Antidepressants were ranked in terms of clinical priority, based on semiquantitative score ratings. Serious v. non-serious reports were compared. RESULTS: A total of 406 reports of neonatal withdrawal syndrome in 379 neonates related to 15 antidepressants were included. Disproportionate reporting was detected for antidepressants as a group as compared to all other drugs (ROR: 6.18, 95% CI 5.45-7.01, IC: 2.07, 95% CI 1.92-2.21). Signals were found for TCAs (10.55, 95% CI 8.02-13.88), followed by other antidepressants (ROR: 5.90, 95% CI 4.74-7.36) and SSRIs (ROR: 4.68, 95% CI 4.04-5.42). Significant disproportionality emerged for all individual antidepressants except for bupropion, whereas no disproportionality for any antidepressant was detected v. methadone. Eleven antidepressants had a moderate clinical priority score and four had a weak one. Most frequent symptoms included respiratory symptoms (n = 106), irritability/agitation (n = 75), tremor (n = 52) and feeding problems (n = 40). CONCLUSIONS: Most antidepressants are associated with moderate signals of disproportionate reporting for neonatal withdrawal syndrome, which should be considered when prescribing an antidepressant during pregnancy, irrespective of class. |
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| ジャーナル名 | Psychological medicine |
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| Pubmed追加日 | 2022/09/22 |
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| 投稿者 | Gastaldon, C; Arzenton, E; Raschi, E; Spigset, O; Papola, D; Ostuzzi, G; Moretti, U; Trifiro, G; Barbui, C; Schoretsanitis, G |
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| 組織名 | WHO Collaborating Centre for Research and Training in Mental Health and Service;Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences,;Section of Psychiatry, University of Verona, Verona, Italy.;Section of Pharmacology, Department of Diagnostics and Public Health, University;of Verona, Verona, Italy.;Pharmacology Unit, Department of Medical and Surgical Sciences, University of;Bologna, Bologna, Italy.;Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim,;Norway.;Department of Clinical and Molecular Medicine, Norwegian University of Science;and Technology, Trondheim, Norway.;Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen;Oaks, NY, USA.;Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra,;Hempstead, NY, USA.;Department of Psychiatry, Psychotherapy and Psychosomatics, Hospital of;Psychiatry, University of Zurich, Zurich, Switzerland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36128628/ |
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