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Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database

Stefania Chiappini Orcid Logo, Laura Orsolini Orcid Logo, John Martin Corkery Orcid Logo, Amira Guirguis Orcid Logo, Alessio Mosca Orcid Logo, Davide Arillotta Orcid Logo, Giovanni Martinotti Orcid Logo, Fabrizio Schifano Orcid Logo

Brain Sciences, Volume: 15, Issue: 11, Start page: 1177

Swansea University Author: Amira Guirguis Orcid Logo

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DOI (Published version): 10.3390/brainsci15111177

Abstract

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...

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Published in: Brain Sciences
ISSN: 2076-3425
Published: MDPI AG 2025
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URI: https://cronfa.swan.ac.uk/Record/cronfa70911
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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&#x2013;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&#x2013;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&#x2013;0.48) and 0.47 (95% CI 0.26&#x2013;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. 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spelling 2026-01-12T21:52:43.5236901 v2 70911 2025-11-15 Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database b49270b9a0d580cf4f31f9a1b6c93f87 0000-0001-8255-0660 Amira Guirguis Amira Guirguis true false 2025-11-15 MEDS 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. Journal Article Brain Sciences 15 11 1177 MDPI AG 2076-3425 eye disorders; opioids; pharmacovigilance; methadone; buprenorphine; FAERS 30 10 2025 2025-10-30 10.3390/brainsci15111177 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee This research received no external funding. 2026-01-12T21:52:43.5236901 2025-11-15T12:48:43.2348259 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Pharmacy Stefania Chiappini 0000-0002-6810-1540 1 Laura Orsolini 0000-0002-6882-3770 2 John Martin Corkery 0000-0002-3849-817x 3 Amira Guirguis 0000-0001-8255-0660 4 Alessio Mosca 0000-0003-3832-1398 5 Davide Arillotta 0000-0002-8843-0595 6 Giovanni Martinotti 0000-0002-7292-2341 7 Fabrizio Schifano 0000-0002-4178-5401 8 70911__35970__717333cb85ad4bfe8953758d0bb64542.pdf 70911.VoR.pdf 2026-01-12T21:50:24.4590102 Output 1227843 application/pdf Version of Record true © 2025 by the authors. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. true eng https://creativecommons.org/licenses/by/4.0/
title Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
spellingShingle Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
Amira Guirguis
title_short Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
title_full Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
title_fullStr Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
title_full_unstemmed Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
title_sort Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database
author_id_str_mv b49270b9a0d580cf4f31f9a1b6c93f87
author_id_fullname_str_mv b49270b9a0d580cf4f31f9a1b6c93f87_***_Amira Guirguis
author Amira Guirguis
author2 Stefania Chiappini
Laura Orsolini
John Martin Corkery
Amira Guirguis
Alessio Mosca
Davide Arillotta
Giovanni Martinotti
Fabrizio Schifano
format Journal article
container_title Brain Sciences
container_volume 15
container_issue 11
container_start_page 1177
publishDate 2025
institution Swansea University
issn 2076-3425
doi_str_mv 10.3390/brainsci15111177
publisher MDPI AG
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Pharmacy{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Pharmacy
document_store_str 1
active_str 0
description 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.
published_date 2025-10-30T05:34:04Z
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