Daiichi-Sankyo: Lixiana journal ad breached overleaf prescribing information signposting rules (AUTH/3506/4/21)

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Key facts

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Case	AUTH/3506/4/21
Company	Daiichi-Sankyo UK Ltd
Product	Lixiana (edoxaban)
Material type	Two-page hard-copy print journal advertisement
Publication	Guidelines in Practice (March 2021, Volume 24, Issue 3)
Placement	Ad page 11; prescribing information overleaf page 12
Job code / prep date	EDX/20/1152; November 2020
Main issue upheld	No reference on the outer page indicating prescribing information was overleaf; CTA to visit website could imply no further info in the ad
Applicable Code year	2019
Complaint received	23 April 2021
Case completed	6 December 2021
Appeal	No appeal
Breach clauses	4.7, 9.1
Sanction	Undertaking received

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

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A complainant (later non-contactable) challenged a two-page hard-copy journal advertisement for Lixiana (edoxaban) in Guidelines in Practice (March 2021, Vol 24, Issue 3).
The ad (job code EDX/20/1152; prepared November 2020) appeared on page 11 with prescribing information (PI) overleaf on page 12.
The ad featured an image of a patient with multiple heads and the claim “24 HOUR STROKE PREVENTION IN ONE DOAC PILL”.
It included pack shots of 30mg and 60mg with the claim “ONCE-DAILY DOAC FOR YOUR AGEING PATIENTS WITH NVAF”.
The outer page stated prominently: “For more information please visit www.lixiana.co.uk”.
The complainant alleged: (1) the imagery implied use in under-75s; (2) the pack shots/claim implied either strength could be used in any ageing NVAF patient; (3) there was no required reference on the outer page indicating PI was overleaf.

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No breach for Allegation 1 (imagery/age implication): Clauses 3.2, 7.2, 9.1 and 2.
No breach for Allegation 2 (dosing implication): Clauses 3.2, 7.2, 7.4, 9.1 and 2.
Breach for Allegation 3 (PI overleaf signposting): Clause 4.7.
Breach for Allegation 3 (standards): Clause 9.1, because the missing overleaf reference plus “For more information please visit www.lixiana.co.uk” could mislead readers into thinking there was no further information in the journal ad.
No appeal.

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