AUTH/3627/4/22 - Complainant v Daiichi Sankyo

Allegations about Lixiana patient information booklets

  • Received
    01 April 2022
  • Case number
  • Applicable Code year
  • Completed
    14 April 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to two booklets created by Daiichi Sankyo for patients prescribed Lixiana (edoxaban).

Whilst the front page of each booklet stated, ‘It’s important to read the Lixiana package leaflet provided with your medicine’, the Panel considered that it might not be clear to all patients that each 20 page booklet was not a substitute for the package leaflet or that the package leaflet contained additional important information on the use of the medicine that was not in the booklet.

The Panel ruled a breach of the following Clauses of the 2021 Code in relation to each booklet for the omission of safety information (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) which, in the Panel’s view, might not be readily recognised as signs of excessive bleeding by the patient, and the misleading impression given that each booklet contained all the relevant information that the patient needed in relation to bleeding, which was incapable of substantiation and might prejudice patient safety:

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the Pharmaceutical industry

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 6.1

Providing misleading information

Breach of Clause 6.2

Misleading impression incapable of substantiation

The Panel ruled no breach of the following Clause of the 2021 Code in relation to each booklet as it did not consider that either booklet implied that the medicine had no side effects or no bleeding risk:

No Breach of Clause 6.4

Requirement that it must not be stated that a product has no adverse reactions       

This summary is not intended to be read in isolation.
For full details, please see the full case report below.