Exploring variables leading to major postmarketing label changes in leading regulatory authorities: a retrospective cohort study in Israel.

Vishkautzan A, Vexberg MH, Berkovitch M, Ashkenazi S, Weiss I, Hershkowitz R, Gorelik E, Maayan H, Ainbinder D, Steinmetz Y, Berar Yanay N, Schlissel O, Shulman K, Azem M, Yarom N, Gutgold N, Divinsky M, Gatt ME, Doron A, Boochnik S, Arcavi L, Trainin M, Marom E, Uziely B, Zevin S, Barchel D, Koren R, Kariv R, Wajntraub C, Hiayev S, Luxenburg O, Ganzel C, Shacham-Shmueli E

Open source

DOI: 10.1136/bmjopen-2025-104073
Published: 2026 Aug 11
Container: BMJ open
Publisher: Not recorded
Open access: yes

Credibility signals

limited evidence Score 45/100 under policy 1.0.0. This is a metadata assessment, not a judgment of the paper's conclusions.

Show all credibility signals

cautionDOI registered: No matching Crossref record was present in this response. Source: Crossref; license: CC0 metadata
cautionDOI resolves: No matching Crossref record was present in this response. Source: Crossref; license: CC0 metadata
not scoredDirectory of Open Access Journals: No matching DOAJ record was present in this response. No allow-list match; this is not evidence of low credibility. Source: DOAJ; license: CC0
not scoredMEDLINE indexed: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
not scoredOpenAlex core source: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
not scoredKnown publisher allow-list: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
not scoredROR affiliation: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
not scoredRetraction Watch expression of concern: No expression of concern notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
not scoredRetraction Watch correction: No correction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
not scoredRetraction Watch reinstatement: No reinstatement notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
not scoredPublication license: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
not scoredPublication version: A publication version was supplied but is not scored. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer

Cite this work

BibTeX

@article{allodium:10.1136/bmjopen-2025-104073,
  title = {Exploring variables leading to major postmarketing label changes in leading regulatory authorities: a retrospective cohort study in Israel.},
  author = {Vishkautzan A and Vexberg MH and Berkovitch M and Ashkenazi S and Weiss I and Hershkowitz R and Gorelik E and Maayan H and Ainbinder D and Steinmetz Y and Berar Yanay N and Schlissel O and Shulman K and Azem M and Yarom N and Gutgold N and Divinsky M and Gatt ME and Doron A and Boochnik S and Arcavi L and Trainin M and Marom E and Uziely B and Zevin S and Barchel D and Koren R and Kariv R and Wajntraub C and Hiayev S and Luxenburg O and Ganzel C and Shacham-Shmueli E},
  year = {2026},
  journal = {BMJ open},
  doi = {10.1136/bmjopen-2025-104073},
  url = {https://doi.org/10.1136/bmjopen-2025-104073}
}

RIS

TY  - JOUR
TI  - Exploring variables leading to major postmarketing label changes in leading regulatory authorities: a retrospective cohort study in Israel.
AU  - Vishkautzan A
AU  - Vexberg MH
AU  - Berkovitch M
AU  - Ashkenazi S
AU  - Weiss I
AU  - Hershkowitz R
AU  - Gorelik E
AU  - Maayan H
AU  - Ainbinder D
AU  - Steinmetz Y
AU  - Berar Yanay N
AU  - Schlissel O
AU  - Shulman K
AU  - Azem M
AU  - Yarom N
AU  - Gutgold N
AU  - Divinsky M
AU  - Gatt ME
AU  - Doron A
AU  - Boochnik S
AU  - Arcavi L
AU  - Trainin M
AU  - Marom E
AU  - Uziely B
AU  - Zevin S
AU  - Barchel D
AU  - Koren R
AU  - Kariv R
AU  - Wajntraub C
AU  - Hiayev S
AU  - Luxenburg O
AU  - Ganzel C
AU  - Shacham-Shmueli E
PY  - 2026
JO  - BMJ open
DO  - 10.1136/bmjopen-2025-104073
UR  - https://doi.org/10.1136/bmjopen-2025-104073
ER  -

APA

A, V., MH, V., M, B., S, A., I, W., R, H., E, G., H, M., D, A., Y, S., N, B. Y., O, S., K, S., M, A., N, Y., N, G., M, D., ME, G., A, D., S, B., L, A., M, T., E, M., B, U., S, Z., D, B., R, K., R, K., C, W., S, H., O, L., C, G., & E, S. (2026). Exploring variables leading to major postmarketing label changes in leading regulatory authorities: a retrospective cohort study in Israel.. BMJ open. https://doi.org/10.1136/bmjopen-2025-104073

Source records

pubmed · retrieved 2026-09-27T10:14:03.985Z