| アブストラクト | Background/Objectives: Recent studies have identified some concerns related to the occurrence of eye disorders in offspring of opioid-prescribed mothers, and especially so in those exposed to methadone. The aim here was to investigate, from a pharmacovigilance point of view, the association between opioid exposure during pregnancy and reported eye disorders in children. Methods: The FDA Adverse Event Reporting System (FAERS) was searched for the following: reports of eye disorders in children aged 0-17 years exposed during pregnancy to either methadone or buprenorphine; top 20 medications administered during pregnancy and associated with eventual occurrence of eye disorders in children; and reports of eye disorders in children from mothers prescribed with a range of psychotropics. Results: For 190 methadone and 79 buprenorphine cases, occurrence of eye disorders was registered as the consequence of having been exposed to these drugs in utero. After data cleaning, residual cases for methadone and buprenorphine were 17 and 15, respectively. Overall, in comparing the odds of eye disorders given methadone exposure to the odds of eye disorders given buprenorphine exposure, which represents a relative Reporting Odds Ratio (ROR) between two drugs, the relative ROR between methadone and buprenorphine was 0.59, suggesting lower odds of eye disorders for methadone compared to buprenorphine in children 0-17 years old antenatally exposed to either methadone or buprenorphine. Conversely, the ROR values resulting from a comparison of methadone- or buprenorphine-related data versus all other psychotropic drugs resulted in 0.27 (95% CI 0.16-0.48) and 0.47 (95% CI 0.26-0.85), respectively, indicating lower reporting odds of eye disorders for these molecules versus the pooled non-opioid comparator group. Medications prescribed during pregnancy which were most frequently related to the occurrence of eye disorders included the following: dupilumab (126 reports), valproate (69 reports), and ibuprofen (52 reports). Indeed, no opiates/opioids appeared among the top 20 drugs linked to eye disorders. A total of 25 and 11 unique cases were associated either with benzodiazepines or antipsychotics, respectively. Conclusions: No potential disproportionality safety signal for eye disorders associated with prenatal opioid exposure was identified. Specifically, the relative ROR indicated lower reporting odds for methadone compared to buprenorphine. The interpretation of these results is complicated by common co-exposures, polydrug interventions, and underlying maternal comorbidities, which introduce substantial confounding in real-world pharmacovigilance data. Overall, these findings highlight the importance of continued systematic post-marketing surveillance. |
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| ジャーナル名 | Brain sciences |
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| Pubmed追加日 | 2025/11/27 |
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| 投稿者 | Chiappini, Stefania; Orsolini, Laura; Corkery, John Martin; Guirguis, Amira; Mosca, Alessio; Arillotta, Davide; Martinotti, Giovanni; Schifano, Fabrizio |
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| 組織名 | School of Medicine, UniCamillus University, Via di S. Alessandro 8, 00131 Rome,;Italy.;Unit of Clinical Psychiatry, Department of Experimental and Clinical Medicine;(DIMSC), Faculty of Medicine and Surgery, Polytechnic University of Marche, 60126;Ancona, Italy.;Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit,;Hertfordshire Medical School, University of Hertfordshire, Hatfield AL10 9AB, UK.;Pharmacy, Medical School, Swansea University, Swansea SA2 8PP, UK.;Department of Neuroscience, Imaging and Clinical Sciences, "G. D'Annunzio";University, 66100 Chieti, Italy.;Department of Neurosciences, Psychology, Drug Research, and Child Health, Section;of Pharmacology and Toxicology, University of Florence, 50121 Florence, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41300183/ |
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