FOI release
FOI Request
Case reference FOI2025/01337
Received 29 December 2025
Published 6 February 2026
Request
I am requesting the following information under the Freedom of Information Act 2000. Please provide documents held by MHRA from the period 2020-2025 relating to psychiatric risks of the following treatments used for headache or migraine, particularly in patients with a diagnosis of bipolar disorder or other psychiatric conditions: 1. Any safety alerts, drug safety updates, internal guidance, or prescribing advice issued by MHRA regarding: * The use of steroid-containing nerve blocks (e.g. local anaesthetic + corticosteroid injections) in patients with bipolar disorder * The use of amitriptyline or nortriptyline for migraine prevention in patients with psychiatric histories 1. Any Yellow Card data (summary-level, no personal data) relating to psychiatric adverse events such as mania, psychosis, or suicidal ideation, following: * Steroid-based nerve blocks for headache/migraine * Low-dose tricyclic antidepressants used for migraine prevention 1. Any internal briefings, policy discussions, or pharmacovigilance reviews where MHRA considered psychiatric risk or contraindications in relation to: * Migraine preventatives prescribed to patients with bipolar disorder or psychosis * The need for clinicians to disclose psychiatric risks before administering steroids or tricyclics If available, please also include any advice MHRA has provided to prescribers or the public about the importance of discussing psychiatric risk (e.g. mania induction) when prescribing these treatments. If this request risks exceeding the cost limit under Section 12, please advise me how to refine it under your Section 16 obligations. I prefer the information in digital format.
Response
See attached
Documents
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