First reported 16 Jun 2016•Latest report 22 Jan 2026
Definition
What this concern includes
Includes deficiencies in patient-facing information, counselling, warnings or discharge communication specifically dedicated to safe apixaban treatment, including advice about bleeding, trauma and when to seek urgent medical help.
Not included
Excludes anticoagulation management protocols or clinical treatment decisions that are not patient-information controls.
Excludes generic deficiencies in patient information governance unless explicitly tied to apixaban safety information.
Excludes information deficiencies concerning other medicines or unrelated hazards.
Excludes failures of hospital referral or trauma assessment unless the reported failure is specifically the apixaban patient-information control.
Reports
3
Distinct published reports
Individual concerns
3
A report can raise multiple concerns
Date range
2016–2026
First to latest report issue date
Stated actions
12
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
Association of the British Pharmaceutical Industry1
East Kent Hospitals University NHS Foundation Trust1
Integrated Care 241
Medicines and Healthcare products Regulatory Agency1
Medicines UK1
South East Coast Ambulance Service NHS Foundation Trust1
University Hospitals Sussex NHS Foundation Trust1
NHS trust2
Independent healthcare provider1
Medicines and medical devices regulator1
Trade association1
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
Inner North London
Concerns raised1
Lack of patient information on actions after head trauma during apixaban treatment
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.4
Action
Notify Bristol Myers Squibb of the coroner’s report and concerns about apixaban product information and patient materials.
Stated by Association of the British Pharmaceutical IndustryStated completedThe respondent said that this action was complete when they made their response on 26 January 2026.
Action
Complete a preliminary assessment of head-trauma warnings for patients taking anticoagulants and discuss the issue at an internal multidisciplinary review meeting.
Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 January 2026.
Action
Conduct a full review of patient information for all direct oral anticoagulants, including apixaban, and warfarin.
Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 26 January 2026.
Action
Seek expert advice on potential updates to anticoagulant product information after finalising the full review.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 26 January 2026.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Position
Changing individual medicines’ product leaflets or labelling is outside the organisation’s regulatory authority.
Stated by Association of the British Pharmaceutical IndustryOutside remitThe respondent said that this matter was outside its role or authority.
Position
The MHRA and marketing authorisation holders are responsible for decisions on statutory labelling, patient information leaflets and licence changes.
Stated by Association of the British Pharmaceutical IndustryRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Existing MHRA pharmacovigilance requirements are considered sufficient because member companies must comply with any regulator-required medicine information changes.
Stated by British Generic Manufacturers Association Ltd trading as Medicines UKExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
North East Kent
Concerns raised1
Failure to provide written and family-shared bleeding-risk advice for direct oral anticoagulant medication
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Create and implement a generic anticoagulant discharge leaflet covering bleeding risks, warning signs and when to seek medical attention.
Stated by East Kent Hospitals University NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 28 October 2022.
West Sussex
Concerns raised1
Lack of a policy for discharge counselling and warning cards for Apixaban
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.7
Action
Launch and maintain a NOAC alert card for patients prescribed apixaban and other new oral anticoagulants.
Stated by University Hospitals Sussex NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 16 June 2016.
Action
Introduce a pharmacy standard operating procedure supporting NOAC alert-card distribution.
Stated by University Hospitals Sussex NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 16 June 2016.
Action
Adopt the Patient First methodology to review the entire NOAC care process.
Stated by University Hospitals Sussex NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 16 June 2016.
Action
Revise the anticoagulant prescribing and administration policy to capture NOAC counselling, consent and written-information standards.
Stated by University Hospitals Sussex NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 16 June 2016.
Action
Establish a multidisciplinary group to design and introduce mechanisms embedding the revised NOAC policy in practice.
Stated by University Hospitals Sussex NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 16 June 2016.
Action
Formalize electronic recording of NOAC counselling discussions.
Stated by University Hospitals Sussex NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 16 June 2016.
Action
Introduce patient leaflets supporting the NOAC alert card.
Stated by University Hospitals Sussex NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 16 June 2016.
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Includes deficiencies in patient-facing information, counselling, warnings or discharge communication specifically dedicated to safe apixaban treatment, including advice about bleeding, trauma and when to seek urgent medical help.
