Daiichi-Sankyo: ‘Add on’ cholesterol ad misleading due to simvastatin contraindication buried in footnote (AUTH/3542/7/21)

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Key facts

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Case	AUTH/3542/7/21
Company	Daiichi-Sankyo UK Ltd
Products	Nilemdo (bempedoic acid); Nustendi (bempedoic acid and ezetimibe); Lixiana (edoxaban)
Material type	Hard copy journal advertisement in Guidelines in practice; two digital banner advertisements for Nilemdo/Nustendi; one digital advertisement for Lixiana
Audience	General practitioners, practice pharmacists and payers
Main issue upheld	Headline “add on” claim misleading because simvastatin >40 mg contraindication/dose restriction was not immediately apparent; footnote too small/not in same visual field
Clauses breached	2; 5.1; 6.1; 6.2
Clauses not breached (as listed on case page)	2; 5.1; 6.1; 6.2; 12.3; 14.5
Sanction	Undertaking received
Complaint received	19 July 2021
Case completed	15 May 2022
Applicable Code year	2021
Appeal	No appeal

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

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An anonymous (initially contactable) health professional complained about Daiichi-Sankyo UK promotional materials in Guidelines in practice (hard copy and digital).
The hard copy journal ad for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) carried the headline claim: “When you and your patients are fighting to take back cholesterol control, add on oral, once-daily NILEMDO or NUSTENDI*”.
The asterisk led to a small footnote stating: concomitant use with simvastatin >40 mg daily is contraindicated; and when coadministered with simvastatin, the simvastatin dose should be limited to 20 mg daily (or 40 mg daily for certain high-risk patients).
The complainant alleged the key simvastatin contraindication/dose restriction was not prominent enough and that the headline could lead to unsafe prescribing.
The complainant also challenged two digital banner ads for Nilemdo/Nustendi for not mentioning simvastatin dosing information and alleged the frames were misleading in isolation.
A separate complaint alleged a Lixiana (edoxaban) digital ad did not have a visible generic name.

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Breach upheld for the hard copy Nilemdo/Nustendi ad: the “add on” claim was misleading in context because the simvastatin >40 mg contraindication was not immediately apparent and the footnote (small font, not in same visual field) did not correct the impression.
No breach for the two Nilemdo/Nustendi digital banner ads on the narrow allegation that omission of simvastatin dosing information made them misleading; on balance the banners did not imply add-on to any lipid-lowering regimen or specifically simvastatin >40 mg.
No breach for the Lixiana digital ad on the narrow allegation that the generic name was “not visible at all” (it appeared beneath the brand name within the logo on each frame).
However, the Panel noted a concern that the non-proprietary name did not appear immediately adjacent to the first appearance of Lixiana as required by Clause 12.3 and asked that Daiichi-Sankyo be advised.
No appeal.

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