BMS/Pfizer v Bayer: Xarelto Eurostroke materials—“protection from day one” and compliance claims ruled misleading

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Key facts

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Case	AUTH/2650/11/13
Complainant	Bristol-Myers Squibb and Pfizer
Respondent	Bayer
Product	Xarelto (rivaroxaban)
Context	Eurostroke Conference (London) promotional exhibition panel and booklet
Materials	Exhibition panel ref L.GB.02.2013.1694c (April 2013); booklet ref L.GB.02.2013.1576c (February 2013)
Main disputed claims	“Highly Effective Protection From Day One”; “Once-daily Xarelto provides fast-acting, 24 hour protection”; “Once-daily dosing improves compliance …” with adherence chart; omission/under-quantification of increased GI bleed risk
Applicable Code year	2012
Complaint received	06 November 2013
Case completed	04 February 2014
Appeal	No appeal
Breaches	Clause 7.2 (x2), Clause 7.4 (x3), Clause 7.10, Clause 9.1 (x2)
No breach	Clause(s) 7.2, 7.4, 7.9 and 9.1 (for other allegations/pages)
Sanctions	Undertaking received; Additional sanctions: Not stated
Published	May 2014 Code of Practice Review

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

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Bristol-Myers Squibb and Pfizer complained about Bayer promotional materials for Xarelto (rivaroxaban) used at the Eurostroke Conference in London (May).
Materials included an exhibition panel (ref L.GB.02.2013.1694c, April 2013) and a promotional booklet (ref L.GB.02.2013.1576c, February 2013) titled “Anticoagulation: why Xarelto matters”.
The exhibition panel stated: “Xarelto … Highly Effective Protection From Day One” under the heading “Efficacy matters:” with a bar chart from Patel et al (2011) comparing Xarelto with warfarin.
The booklet included claims and presentations about safety (page 4), simplicity and “fast-acting, 24 hour protection” (page 5), compliance/adherence advantages for once-daily dosing (page 6), and a summary page (page 8) that highlighted safety benefits but omitted the increased GI bleed risk.
Key issues were whether claims implied measurable clinical stroke prevention from day one, whether adherence/compliance claims were being implied for Xarelto specifically, and whether safety information was presented in a fair and balanced way (including GI bleeding risk).

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Breach: “Highly Effective Protection From Day One” was ruled exaggerated and not capable of substantiation.
No breach: Page 4 not stating the primary efficacy endpoint was not misleading in the context of a safety page (given non-inferiority vs warfarin).
Breach: Failure to quantify the increased risk of GI bleeding (while quantifying other bleeding outcomes) was misleading.
No breach: “Even in your fragile patients, Xarelto has an established safety profile” was not an absolute safety claim and was considered substantiated.
No breach: “Simplicity matters” was acceptable in context (once-daily dosing regimen) and did not underplay anticoagulation complexity.
Breach: “Once-daily Xarelto provides fast-acting, 24 hour protection” was exaggerated and not capable of substantiation (implied fast measurable stroke/systemic embolism prevention).
Breach: Page 6 compliance chart/claims implied proven compliance for once-daily Xarelto vs twice-daily alternatives; ruled misleading, not substantiated, and not meeting high standards.
No breach: Use of “simple” on page 8 was acceptable when clearly linked to dosing regimen.
Breach: Page 8 was misleading for omitting the increased GI bleed risk while highlighting other safety advantages; high standards not maintained.
No appeal.

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