abpi
• The ABPI made the originator company, Bristol Myers Squibb (BMS), aware of the report and the coroner’s concerns.
AI-generated concerns summaryThe coroner identified a gap in apixaban patient information leaflets, which do not expressly advise on steps to take following head trauma. This absence of specific guidance may lead to delays in seeking medical advice, particularly for patients on anticoagulants, contrary to NICE guidelines for head injuries.
• The ABPI made the originator company, Bristol Myers Squibb (BMS), aware of the report and the coroner’s concerns.
• Member companies will comply with any future changes to product information required by the MHRA.
• The agency completed a preliminary assessment and discussed the issue at an internal multidisciplinary meeting. • A full review of all Direct Oral Anticoagulants and warfarin is currently underway. • The agency will seek expert advice on potential product information updates after the review is finalised.
Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 19 Mar 2026 (estimated from the report date).