AUTH/3497/3/21: Daiichi Sankyo – Lixiana websites (misleading lactose and renal impairment dosing presentation) | PMCPA Case

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Key facts

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Case	AUTH/3497/3/21
Company	Daiichi Sankyo
Product	Lixiana (edoxaban)
Materials	HCP website lixiana-hcp.co.uk (refs EDX/21/0176; EDX/20/1123; contact page EDX/20/1121) and patient-directed website myanticoagulant.co.uk (EDX/20/1264)
Main upheld issues	“Lactose not listed as an excipient” presented with “0%” milk icon and caveat only in footnote; renal impairment reduced-dose section implied suitability across all renal impairment stages and omitted prominent ESRD/dialysis “not recommended” information
Breach clauses	7.2, 9.1
No breach clauses (listed on case page)	2, 4.1, 7.2, 7.9, 9.1, 14.1, 26.1, 26.2, 28.1
Applicable Code year	2019
Complaint received	27 March 2021
Case completed	16 December 2021
Appeal	No appeal
Sanction	Undertaking received

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

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An anonymous complainant challenged content on two Daiichi Sankyo websites relating to Lixiana (edoxaban): an HCP site (lixiana-hcp.co.uk) and a patient-directed site (myanticoagulant.co.uk).
Multiple allegations were made including: misleading “ageing patients” positioning, implications of “safe” via “safety profile” language, use of footnotes to qualify claims, a “contact us” page allegedly soliciting medical information enquiries, and alleged public promotion / missing prescribing information on the patient site landing page.
The Panel upheld two issues on the HCP site where the overall impression to a busy health professional was misleading due to prominence/omission and reliance on footnotes.

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Breach found: Clause 7.2 and Clause 9.1 (two separate webpage elements on the HCP site).
No breach for the remaining allegations, including Clauses 2, 4.1, 7.9, 14.1, 26.1, 26.2 and 28.1 (and no breach for several Clause 7.2/9.1 allegations not established by the complainant).
No breach of Clause 2 was ruled (the Panel did not consider the circumstances warranted particular censure).

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