What happened

• A general practitioner complained about a page from a six-page, landscape, gatefold leavepiece promoting Eliquis (apixaban) (ref PP-ELI-GBR-4453) issued by Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited.
• The page headline stated: “Eliquis is the only factor Xa inhibitor that does not require a dose adjustment in patients with NVAF who have mild or moderate renal impairment*”.
• The page included a table comparing renal-impairment dose adjustment for Eliquis versus rivaroxaban, edoxaban and dabigatran, using colour shading.
• The table stated “no dose adjustment” for Eliquis in normal renal function and mild/moderate renal impairment, with an asterisk leading to a small-font footnote describing Eliquis dose-reduction criteria (age, weight, serum creatinine) and severe renal impairment dosing.
• The complainant alleged the presentation was misleading and could lead to patient harm if clinicians missed the asterisk/footnote and failed to adjust dose according to the licence.
• The complainant also alleged the page was designed to give unfair advantage over competitor medicines.
• The Alliance said the leavepiece was designed to be read in a specific sequence and included prominent dosing criteria on another panel; it also stated the leavepiece had been withdrawn in June 2019 due to a prescribing information update and a revised version was later approved.
• The Panel considered there was no evidence about the order recipients would read the leavepiece and reiterated the principle that each page must be able to stand alone for Code compliance and could not rely on qualification on another page or in a footnote.

Outcome

• The Panel ruled the table and headline implied no Eliquis dose adjustment was needed in all NVAF patients with mild to moderate renal impairment, which was not so, and found the immediate impression misleading; the small-font footnote and dosing information on another page were insufficient to qualify it.
• The Panel ruled the dosing information and headline did not accurately reflect the Eliquis SPC for NVAF patients with normal renal function or mild/moderate renal impairment and was inconsistent with the SPC.
• The Panel ruled the comparison misleading because it implied Eliquis was the only NOAC not requiring dose adjustment in moderate renal impairment, which was not so.
• The Panel ruled failures to maintain high standards and that the matter brought discredit upon and reduced confidence in the industry due to patient safety implications.
• On appeal, the Alliance accepted breaches of Clauses 3.2, 7.2 and 7.3, but appealed Clause 9.1 and Clause 2.
• The Appeal Board upheld the Panel’s rulings for Clause 9.1 (high standards) and Clause 2 (discredit), noting busy health professionals might scan and focus on the traffic-light table and that the page was insufficient when viewed in isolation for appropriate prescribing decisions.
• Complaint received: 21 June 2019. Case completed: 13 May 2020.

Clauses

• Clause 7.2: Breach ruled (misleading impression; insufficient qualification by small footnote/other page).
• Clause 3.2: Breach ruled (promotion inconsistent with the Eliquis SPC dosing recommendations).
• Clause 7.3: Breach ruled (misleading comparison implying Eliquis uniquely required no adjustment in moderate renal impairment).
• Clause 9.1: Breach ruled (failure to maintain high standards); upheld on appeal.
• Clause 2: Breach ruled (brought discredit upon and reduced confidence in the industry due to patient safety implications); upheld on appeal.

Sanctions

No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

ABPI signatory lens

Why this matters: Dosing claims that can be read as “no adjustment needed” are high-risk because they can directly affect prescribing decisions. The rulings emphasise that patient safety and SPC-consistency must be clear even to a time-pressured reader scanning a single page.

Where teams typically slip up (interpretation):

• Relying on “flow” or other panels in a multi-panel piece to qualify a strong headline claim, instead of making each page self-sufficient.
• Using footnotes (especially small font) to correct the main impression created by a headline/table.
• Using colour/visual cues (e.g., traffic-light shading) that imply a simple “go/no-go” decision when the clinical rule is conditional.

The control that would have prevented it: A mandatory “page-in-isolation” compliance check for every panel/table (including visual design review) to confirm the primary take-home message remains accurate and SPC-aligned without relying on footnotes or other pages.

What I’d check in the job bag:

• Final artwork of each panel/page reviewed as a standalone item, with documented signatory approval against the SPC (especially Section 4.2 dosing and renal impairment wording).
• Substantiation pack showing how the headline and table wording were derived from the SPC, including rationale for any simplification.
• Readability evidence: font sizes for footnotes, prominence testing, and any internal review comments about the traffic-light system and potential misinterpretation.
• Comparative claims governance: confirmation that competitor dosing statements and any “only” claims were checked for accuracy and context, and that the comparison does not create a misleading overall impression.
• Withdrawal/change-control records (e.g., June 2019 withdrawal and subsequent revision) and the CAPA/continuous improvement actions referenced in the appeal.

What the sanctions tell you (interpretation):

• Even without explicit extra sanctions listed, upheld Clause 2 and 9.1 findings signal the Authority viewed the risk as serious because it related to dosing and patient safety.
• Acceptance of some breaches did not mitigate the standards/discredit findings where the material could be misread in isolation.
• Design choices (like traffic-light tables) can elevate risk if they encourage oversimplified clinical decisions.

3 questions to ask your team this week:

1. If a prescriber only reads the headline and table on one page, could they make an unsafe or SPC-inconsistent decision?
2. Are we using footnotes to “fix” the main message, and if so, should the main claim be rewritten instead?
3. Do our comparative visuals (colour coding, “only” claims) create an overall impression that remains true under the SPC conditions?

Key facts

Download the full case report (PDF)

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