FOI release
Evidence and decision-making behind January 2024 fluoroquinolone prescribing restrictions
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00917
Received 18 August 2026
Published 18 September 2026
Request
I am writing to request information under the Freedom of Information Act 2000 regarding the MHRA Drug Safety Update published on 22 January 2024 titled: "Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate." https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-must-now-only-be-prescribed-when-other-commonly-recommended-antibiotics-are-inappropriate The published update states that MHRA reviewed the effectiveness of previous measures to reduce the risk of disabling, long-lasting or potentially irreversible side effects from systemic fluoroquinolones, sought advice from the Commission on Human Medicines, and then took additional regulatory action to update the indications for systemic fluoroquinolones. Please provide the following recorded information. 1. The MHRA review referred to in the Drug Safety Update Please provide the full review, report, briefing paper, evidence assessment, safety assessment, or equivalent document that supported the January 2024 regulatory action. 2. Terms of reference, scope and methodology Please provide any documents setting out the scope, terms of reference, methodology, inclusion/exclusion criteria, data sources, date ranges, analytical methods, or review questions used for the MHRA review. 3. Evidence on the effectiveness of the 2019 restrictions Please provide the evidence used to assess whether the 2019 restrictions had been effective. This should include, where held, prescribing data, trend analyses, audit data, Yellow Card reporting trends, healthcare-professional awareness data, compliance assessments, or any other evidence used to judge the effectiveness of the 2019 measures. 4. Commission on Human Medicines advice Please provide the CHM papers, minutes, recommendations, advice, briefing notes, slides, annexes or decision records relating to fluoroquinolone safety and the January 2024 restriction. I am happy for personal data to be redacted. 5. Basis for the estimated frequency of serious reactions The update states that disabling and potentially long-lasting or irreversible adverse reactions are estimated to occur in at least between 1 and 10 people per 10,000 patients, while also stating that the frequency cannot be estimated precisely. Please provide the analysis, data sources, calculations, assumptions and denominator information used to derive this estimate. 6. Case definitions and classification criteria Please provide any documents defining or classifying terms such as "disabling," "long-lasting," "potentially irreversible," "serious adverse reaction," "multi-system," and "fluoroquinolone-associated disability," if such terms were used in the review. 7. Drug-specific and route-specific analyses Please provide any analyses, tables or summaries comparing risks across individual fluoroquinolones, including ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin and delafloxacin, and across routes of administration, including oral, injection and inhaled use. 8. Risk-factor analysis Please provide any evidence or analyses used to support the warnings relating to older age, renal impairment, solid-organ transplantation, corticosteroid coadministration, prior serious adverse reactions, treatment duration, dose, indication, or other patient-level risk factors. 9. Mechanistic evidence Please provide any literature reviews, briefing notes or evidence summaries considered by MHRA relating to proposed mechanisms of fluoroquinolone toxicity, including tendon injury, mitochondrial dysfunction, oxidative stress, neuropathy, psychiatric effects, sensory effects, connective-tissue injury or delayed adverse reactions. 10. Patient evidence and stakeholder input Please provide any summaries of patient reports, patient-group submissions, stakeholder consultation, expert submissions, qualitative evidence, meeting notes or correspondence that informed the review, particularly evidence relating to long-lasting disability and patient reports of not being adequately acknowledged by healthcare professionals. 11. Decision rationale and benefit-risk assessment Please provide the documents explaining the rationale for the final wording that systemic fluoroquinolones must now only be used when other commonly recommended antibiotics are inappropriate. Please include any benefit-risk assessment, options appraisal, regulatory impact assessment or implementation assessment. 12. Implementation and communication planning Please provide any documents relating to the implementation of the January 2024 restrictions, including communication plans, updates to product information, Dear Healthcare Professional communications, engagement with NICE, NHS England, professional bodies, GP prescribing systems, antimicrobial stewardship teams, patient-facing materials, or monitoring plans. 13. Correspondence with marketing authorisation holders Please provide correspondence, instructions, assessment reports or variation documents sent to or received from marketing authorisation holders concerning the January 2024 fluoroquinolone indication changes and safety information updates. 14. Conflicts of interest Please provide any declarations of interest, conflict-of-interest summaries or management plans for committee members, experts or external contributors involved in the review and decision-making process. Please provide the information electronically, preferably in PDF, Word, CSV or Excel format where appropriate. For numerical data, I would prefer machine-readable tables rather than scanned documents. I am not requesting personal data of patients or members of the public. Please redact personal data where necessary and disclose the remaining information. If any information is withheld, please identify the exemption relied upon and provide the reasoning and public-interest test where applicable. Please also provide a schedule of withheld documents where possible. I would be grateful if you could acknowledge receipt of this request. I understand that public authorities normally respond to FOI requests within 20 working days.
Response
See attached
Documents
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