FOI release
FOI Act 2000 Request – Fluoroquinolone Prescribing Restrictions and Safety Data
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 FOI2026/01125
Received 23 September 2026
Published 6 November 2026
Request
Under the Freedom of Information Act 2000, I'm writing to request access to specific recorded data, internal communications, and decision-making records held by the MHRA regarding the regulation and safety monitoring of fluoroquinolone antibiotics. Please find my detailed, itemised queries listed below for your review within the statutory 20-working-day timeframe. Thank you. 1. Please provide the specific recorded data, epidemiological studies, or statistical models used by the MHRA to calculate and conclude that the minimum frequency of disabling fluoroquinolone side effects is between 1 and 10 per 10,000 patients (the ‘rare’ classification), as published in the January 2024 Drug Safety Update. Please provide: a) Any internal assessments, reports, or statistical adjustments held by the MHRA regarding the estimated underreporting rate to the Yellow Card Scheme for fluoroquinolone-associated disability (FQAD). b) Any recorded risk-benefit evaluations or safety committee papers discussing how the lack of a specific NHS SNOMED or ICD-10 diagnostic code for FQAD impacts the MHRA’s ability to capture the true clinical incidence of these adverse events. c) The official confidence intervals or sensitivity analyses recorded in the MHRA's safety reviews regarding the accuracy of this "rare" statistical incidence. 2. Please share correspondence and shared data between the MHRA and the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) between 2016 and 2024 regarding safety signals for peripheral neuropathy and aortic aneurysm risks in fluoroquinolones. 3. Please provide minutes of meetings, scientific rationales, and internal correspondence from the Commission on Human Medicines (CHM) or MHRA safety committees regarding the decision to update the estimated incidence of disabling side effects from very rare (2019) to a minimum frequency of 1 to 10 per 10,000 patients in the January 2024 update. 4. Please provide copies of all official correspondence, guidance documents, letters, and alerts sent by the MHRA to healthcare professionals, clinical bodies, and NHS organisations regarding the implementation of safety restrictions on fluoroquinolone antibiotics, regarding both the March 2019 Drug Safety Update and the January 2024 Drug Safety Update. Specifically, any direct alerts, DHPCs, or implementation guidance sent to clinical networks, Royal Colleges, or NHS Trusts regarding the initial introduction and the subsequent tightening of these prescribing restrictions. 5. Please provide the internal documentation, meeting minutes, and scientific rationales concerning the decision-making process to issue the August 2023 Drug Safety Update reminder regarding the March 2019 fluoroquinolone restrictions. Specifically, include: 1. Minutes of meetings held by the Commission on Human Medicines (CHM) or its expert advisory groups where the necessity of an August 2023 safety reminder was discussed 2. Any reports, statistical data summaries, or influxes of Yellow Card adverse drug reaction (ADR) reports reviewed by the MHRA between January 2022 and August 2023 that prompted the decision to issue this specific reminder. 6. Please provide a complete breakdown of all Yellow Card adverse drug reaction (ADR) reports for systemic fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) from 2019 to 2025, specifically broken down by patient age groups, gender, and the duration of the reported disability. 7. Please provide any internal reviews, audits, or data held by the MHRA assessing clinical compliance with the January 2024 Drug Safety Update restrictions on fluoroquinolones, including data on overall UK prescribing volume drops before and after the alert. 8. Please clarify the internal organizational structure of the MHRA by identifying the specific Divisions, Units, or Expert Advisory Groups currently responsible for: 1. The final regulatory decision-making process to restrict fluoroquinolone antibiotics (including the specific expert committees or panels involved in reviewing the benefit-risk profile). 2. The post-marketing surveillance and active collection of data (such as Yellow Card adverse drug reaction reports and real-world data networks) used to identify safety signals and inform these restrictions. 3. The dissemination of updated drug safety advice and restrictions directly to frontline clinicians and professional medical bodies (such as the team responsible for publishing the monthly Drug Safety Update and distributing Direct Healthcare Professional Communications). 9. Please clarify the MHRA’s role, policy, and internal process regarding the request or introduction of new clinical diagnostic codes (such as SNOMED CT or ICD-10 terms) within UK clinical practice. Specifically, please provide: 1. Any documentation or standard operating procedures detailing how the MHRA interacts with NHS England’s Terminology and Classifications Delivery Service to request new codes following severe drug safety signals. 2. Details of any active or past requests made by the MHRA to NHS England between 2019 and 2024 to establish unique diagnostic codes specifically related to fluoroquinolone-induced toxicity or long-term adverse events.
Response
See attached
Documents
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