Daiichi Sankyo breached the ABPI Code over Lixiana patient booklets that omitted key bleeding warning signs (AUTH/3627/4/22)

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Key facts

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Case	AUTH/3627/4/22
Company	Daiichi Sankyo
Complainant	Contactable complainant (health professional)
Product	Lixiana (edoxaban)
Materials	Two patient booklets: “Understanding your treatment for atrial fibrillation” (EDX/21/0229, March 2021) and “Understanding your treatment for venous thromboembolism” (EDX/20/1071, December 2020)
Main issue	Omission of PIL-listed signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) and misleading impression that the booklet contained all relevant bleeding safety information
Applicable Code	2021
Complaint received	1 April 2022
Case completed	14 April 2023
Appeal	No appeal
Breach clauses	2, 5.1, 6.1, 6.2
No breach clauses	6.4
Sanctions	Undertaking received; Additional sanctions: Advertisement

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A health professional complained about two Daiichi Sankyo patient booklets for Lixiana (edoxaban): Understanding your treatment for atrial fibrillation (EDX/21/0229, March 2021) and Understanding your treatment for venous thromboembolism (EDX/20/1071, December 2020).
Both 20-page booklets included a page titled “What about potential side effects?” (page 16) listing signs of bleeding and advising patients to speak to their doctor immediately if they experienced them.
The complainant alleged the booklets omitted important safety information from section 4 of the Lixiana patient information leaflet (PIL): signs of excessive bleeding (“exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling”) and the instruction to consult a doctor immediately.
Although each booklet’s front page stated “It’s important to read the Lixiana package leaflet provided with your medicine”, the Panel considered it might not be clear to all patients that the booklet was not a substitute for the package leaflet and that the leaflet contained additional important information not in the booklet.
The Panel considered the overall impression was that the side effects list (and surrounding content such as “Is there anything else you should consider when taking Lixiana?”) implied the booklet contained all the important information needed, particularly about bleeding.

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Breach found for each booklet due to omission of PIL safety information and the misleading impression that the booklet contained all relevant information needed about bleeding.
No breach found for the allegation that the booklets implied Lixiana had no side effects or no bleeding risk.
No appeal.

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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
No Breach of Clause 6.4 Requirement that it must not be stated that a product has no adverse reactions

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