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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.
Published: 18 September 2026
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Freedom of Information Act 2000 request I request recorded information held by the Medicines and Healthcare products Regulatory Agency concerning the relationship between Post-Finasteride Syndrome (PFS) and MedDRA Preferred Term (PT) 10082430, “Post 5-alpha-reductase inhibitor syndrome”, within the MHRA Yellow Card/pharmacovigilance system. For precise identification, I refer to MedDRA Change Request 2018325008 and MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, implemented on 29 November 2018. The principal purpose of this request is to establish from existing MHRA records whether “Post 5-alpha-reductase inhibitor syndrome” is the broader pharmacovigilance/coding concept under which a finasteride-specific case described by a reporter as “Post-Finasteride Syndrome” or “PFS” can fall. I am requesting existing recorded information only. I am not asking the MHRA to create a new medical opinion, establish individual causation, or make a new determination concerning the clinical status of PFS. 1. Implementation of MedDRA PT 10082430 Please provide recorded information establishing: * whether MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, is or has been implemented within the terminology used by the MHRA for Yellow Card/pharmacovigilance reports; * the date and MedDRA version from which it became available within the relevant MHRA system; * whether PT 10082430 can be used to code, classify, retrieve, aggregate or analyse suspected adverse-reaction reports; and * its relevant MedDRA terminology status and hierarchy as implemented or used by the MHRA. Where this information exists as a database or terminology entry rather than a conventional document, please provide an extract, screenshot, printout or equivalent recorded representation where reasonably practicable. 2. Finasteride and PT 10082430 Please provide existing recorded information establishing whether finasteride, as a 5-alpha-reductase inhibitor, is a medicinal product whose suspected adverse-reaction reports are capable of falling within or being associated with MedDRA PT 10082430. Specifically, please provide recorded information showing whether a Yellow Card report involving finasteride can be: * coded under PT 10082430; * mapped to PT 10082430; * retrieved through PT 10082430; * aggregated or analysed using PT 10082430; or * otherwise represented under PT 10082430 for pharmacovigilance or signal-detection purposes. 3. Post-Finasteride Syndrome / PFS This is the principal part of my request. Where a Yellow Card report: (a) identifies finasteride as the suspected medicinal product; and (b) expressly describes a persistent post-treatment condition using the reporter terminology “Post-Finasteride Syndrome” or “PFS”, please provide the existing recorded information establishing whether that report is capable of being: * coded under; * mapped to; * classified under; * retrieved through; * aggregated under; or * otherwise represented by MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”. If “Post-Finasteride Syndrome” or “PFS” is not itself a MedDRA Preferred Term or Lowest Level Term, please provide any existing MHRA coding rule, terminology mapping, guidance, database documentation or other recorded information identifying how reporter wording expressly describing PFS is represented. If another MedDRA term would instead apply, please identify that term and its code where this information is held. 4. Broader/umbrella relationship Please provide any recorded information establishing whether MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, functions as the broader pharmacovigilance or coding concept capable of encompassing a finasteride-specific report described as Post-Finasteride Syndrome/PFS. In particular, please provide any existing terminology hierarchy, mapping, coding rule, guidance, database documentation or other recorded information demonstrating the relationship, if any, between: Finasteride → Post-Finasteride Syndrome/PFS → MedDRA PT 10082430 “Post 5-alpha-reductase inhibitor syndrome”. For clarity, by “broader/umbrella concept” I mean a pharmacovigilance or terminology category capable of encompassing a finasteride-specific report. I am not asking the MHRA to adopt “umbrella term” as a new clinical definition. 5. Persistent post-treatment effects and scope Please provide any recorded definition, MedDRA documentation, coding guidance or other information held or used by the MHRA concerning the scope of PT 10082430. In particular, please provide recorded information establishing whether PT 10082430 encompasses reports of effects or symptoms which develop during or following exposure to a 5-alpha-reductase inhibitor and persist following discontinuation. Please also provide any recorded information establishing whether this includes reports involving finasteride. Where held, please provide recorded information concerning the categories of persistent effects capable of being represented or associated with PT 10082430, including reported: * cognitive or neurological symptoms; * psychiatric symptoms; * sexual or reproductive symptoms; * fatigue or related systemic symptoms; and * any other categories recorded as falling within the scope of PT 10082430. For clarity, I am requesting information concerning the scope and coding of reported effects, not asking the MHRA to establish a particular biological mechanism. 6. Central question To ensure that the principal information sought is unambiguous: Where finasteride is the suspected medicinal product and a Yellow Card reporter describes a persistent post-treatment condition as “Post-Finasteride Syndrome” or “PFS”, is that report capable of falling within, being coded or mapped to, or being retrieved or aggregated under MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”? Please provide the existing recorded information establishing the answer. If MHRA records establish that the answer is yes, please provide the relevant record(s), terminology entry, database extract, mapping, coding guidance or other recorded information establishing that relationship. If MHRA records establish that the answer is no, please provide the recorded information establishing that distinction and, where held, identify the alternative MedDRA terminology under which a report expressly described as PFS would be represented. If the MHRA holds no recorded information establishing either position, please state explicitly that no such recorded information is held. 7. Historical information Where held and readily identifiable, please also provide: * the date on which PT 10082430 was first implemented within the MHRA pharmacovigilance system; * the earliest date on which the MHRA recorded a Yellow Card report under PT 10082430, without disclosure of patient-identifiable information; and * any existing MHRA coding or terminology guidance specifically addressing finasteride in connection with PT 10082430. 8. Form and provenance of disclosure Please provide the information electronically. Where responsive information exists as a database entry, terminology record, electronic field, coding rule or other electronic record rather than a conventional document, please provide an extract, screenshot, printout or equivalent copy where reasonably practicable. Where reasonably practicable, please preserve identifying information associated with the disclosed records, including: * document titles and dates; * MedDRA/terminology version numbers; * database field headings; * originating MHRA department where recorded; and * other contextual metadata necessary to establish the source and date of the disclosed information. If responsive information is already publicly available, please identify the specific document, terminology record and relevant section or entry, rather than referring generally to the MHRA, Yellow Card or MedDRA websites. If any requested information is withheld, please identify the specific exemption under the Freedom of Information Act 2000 relied upon and explain its application. If compliance with any discrete part of this request would exceed the appropriate cost limit, please provide the remainder of the information that can be supplied and provide advice and assistance concerning how the affected portion may be refined.
Published: 18 September 2026
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Dear MHRA, I am hoping you can provide an update to FOI 24/352 and whether any more incidents relating to the safety of performing MRI scans in patients with embolization coils and vascular plugs since this request was responded to. Could I please add to the request that I would like to request the incident details themselves, not simply the number of incidents up until the current date. I understand these details will have to be anonymised.
Published: 18 September 2026
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I am requesting recorded information concerning cases of iatrogenic botulism associated with cosmetic botulinum toxin treatment, and evidence or statistics supplied to the MHRA by Save Face and the Joint Council for Cosmetic Practitioners. This request follows public statements about the 2025 outbreak and the MHRA's subsequent Drug Safety Update of 15 July 2026. The JCCP has published the following statement concerning the 2025 cases: "Between 4 June and 14 July 2025, the UK Health Security Agency (UKHSA) confirmed 38 cases of iatrogenic botulism in England, which were traced to unlicensed or counterfeit botulinum toxin injections in nonclinical settings." Save Face has separately stated publicly that the number of Botox-related complaints it received increased by more than 350% between 2019 and 2024. It has also stated that, across its reporting years, more than 80% of complainants were treated by a non-healthcare practitioner and that recent complaints commonly concerned products not approved for use in the UK. The MHRA Drug Safety Update published on 15 July 2026 describes iatrogenic botulism following botulinum toxin treatment as rarely reported. It also identifies JCCP and Save Face among the organisations involved in stakeholder engagement. Against that background, please provide the following recorded information. For the period 1 January 2025 to the date of this request: The number of reports received by the MHRA concerning suspected iatrogenic botulism following cosmetic use of botulinum toxin, broken down by calendar year. Where held, the number of those reports that were subsequently: a. clinically confirmed as iatrogenic botulism; b. considered probable or suspected; c. not confirmed. For those cases, where recorded, the number involving: a. a botulinum toxin product authorised for use in the UK; b. an unlicensed or unauthorised product; c. a counterfeit product; d. a product whose identity or regulatory status could not be established. Where recorded, the name or brand of the product involved in each case, together with whether it was licensed, unlicensed, suspected counterfeit or unidentified. Personal information about patients is not requested. The number of relevant Yellow Card reports received during 2025 and 2026. The number of cases referred to, investigated by, or otherwise considered by the MHRA Criminal Enforcement Unit. Where this information is recorded, the professional status of the person who administered the product, including whether they were a doctor, dentist, nurse, pharmacist, other regulated healthcare professional, independent aesthetic practitioner, beautician, other practitioner category, or unknown. Where recorded, the treatment setting, including clinic, salon, home, mobile setting, other premises or unknown. Any statistical information, datasets, case summaries, complaint figures, briefings or other evidence supplied to the MHRA by Save Face concerning botulinum toxin, Botox-related complaints, unlicensed products, counterfeit products or iatrogenic botulism from 1 January 2024 onwards. Any equivalent statistical information, datasets, case summaries, complaint figures, briefings or other evidence supplied by the JCCP during the same period. Any recorded assessment, verification, checking or discussion by the MHRA concerning the methodology, provenance, reliability or evidential status of figures supplied by Save Face or JCCP. Correspondence between the MHRA and Save Face or JCCP concerning iatrogenic botulism, the 2025 outbreak, unlicensed or counterfeit botulinum toxin, or the July 2026 Drug Safety Update. Any recorded information showing what evidence led the MHRA to include Save Face and JCCP in the stakeholder engagement identified in the Drug Safety Update of 15 July 2026. Electronic copies are preferred. I am not requesting patient-identifiable information. Where records contain personal information, please redact that material and disclose the remainder rather than withholding documents in their entirety. If any part of this request would exceed the appropriate cost limit, please provide advice and assistance under section 16 of the Freedom of Information Act 2000 so that the request can be narrowed while preserving the principal questions concerning case numbers, product status and evidence supplied by Save Face and JCCP.
Published: 18 September 2026
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Published: 18 September 2026
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I am writing to submit a Freedom of Information (FOI) request for the following document: * Remicade – CTD Sections 2.7.2 and 2.7.3 for Crohn's Disease (CD) and Ulcerative Colitis (UC), Pediatric Phase 3
Published: 18 September 2026
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Batch Product Date administered E5019 Diphtheria, tetanus, pertussis (triple) with polio 11 January 1996 E5019 Diphtheria, tetanus, pertussis (triple) with polio 13 February 1996 E5015 Diphtheria, tetanus, pertussis (triple) with polio 26 March 1996 HB15350 Measles, mumps and rubella (MMR) 31 December 1996 HJ11120 Measles, mumps and rubella (MMR), booster 27 March 2000 N1156-51 S125PP Diphtheria/tetanus (double) with polio, booster 27 March 2000 2 | P a g e For each of the six batches listed above, please provide: 1. The product name and the marketing authorisation holder or manufacturer. 2. The UK batch release certification issued in respect of that batch, including any independent testing carried out by the National Institute for Biological Standards and Control, and the certificate of analysis or equivalent release documentation. 3. Details of any out-of-specification, out-of-trend, or non-conforming test result recorded against that batch at any stage of release testing. 4. Details of any quality defect investigation, manufacturer field alert, recall, quarantine, or Drug Alert notice issued in relation to that batch. 5. The number of Yellow Card adverse reaction reports recorded against that batch number, broken down by reaction category. Additionally: 1. For batches E5019 and E5015 specifically, the thiomersal content per dose expressed in micrograms of ethylmercury, together with the specification range for that product at the time of release. 2. For the Haemophilus influenzae type b (Hib) vaccine in routine NHS use in England between January and March 1996: the product name, the marketing authorisation holder, and the thiomersal content per dose. 3. Any quality defect investigation, recall, or Drug Alert notice issued in respect of any DTwP or Hib batch distributed in England between January and June 1996.
Published: 18 September 2026
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All Requests for Further Information (RFIs), deficiency letters and assessor questions issued during the assessment PL 16363/0755, PL16363/0754 The applicant's responses to those questions. Any CHM advice or recommendations
Published: 18 September 2026
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Can you please provide clinical and non clinical for PL 12762/0544-0547
Published: 18 September 2026
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Dear Madam or Sir, I would like to request the following information under the Freedom of Information Act (FOIA): Could you please kindly provide me with the information on whether the variations presented in the attached document have been approved by the MHRA for the following drug products: Lantus 100 units/ml solution for injection in a vial (PLGB 04425/0814) Lantus 100 units/ml solution for injection in a cartridge (PLGB 04425/0815) Lantus SoloStar 100 units/ml solution for injection in a prefilled pen (PLGB 04425/0816) MAH of the drug products is Aventis Pharma Limited (trading as Sanofi). The approval dates for EU drug product Lantus (EMEA/H/C/000284) from the EMA homepage are provided to give an approximative understanding of the timelines.
Published: 18 September 2026
