AUTH/2537/10/12: Anonymous v Bayer – Xarelto ad claim “one tablet, once daily, simple” (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2537/10/12
Complainant	Anonymous, non-contactable
Company	Bayer HealthCare
Medicine	Xarelto (rivaroxaban)
Material	Two-page advertisement in GP (24 October 2012), ref L.GB.09.2012.0568h
Key claim at issue	“one tablet, once daily, simple” (in relation to stroke prevention in AF)
Clauses considered	2, 3.2, 7.2, 7.9, 9.1
Decision	No breach of the Code
Complaint received	29 October 2012
Case completed	28 November 2012
Applicable Code year	2012
Appeal	No appeal

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

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An anonymous, non-contactable complainant challenged a two-page Bayer HealthCare advertisement for Xarelto (rivaroxaban) published in GP on 24 October 2012 (ref L.GB.09.2012.0568h).
The ad, in the context of stroke prevention in atrial fibrillation (AF), included the phrase: “one tablet, once daily, simple”.
The complainant alleged the ad was “outrageous” because anticoagulants carry serious bleeding risks and require careful consideration and monitoring.
The complainant argued describing Xarelto as “simple” did not reflect the inherent risks of anticoagulants and was not supported by the prescribing information (including cautions/dose reductions in renal impairment and extensive contraindications/warnings/interactions).
The PMCPA asked Bayer to consider Clauses 2, 3.2, 7.2, 7.9 and 9.1.
Bayer responded that “simple” referred to the dosing regimen (once daily for key indications) and contrasted this with the complexity of warfarin management (INR monitoring, dose adjustments, multiple strengths, interactions).

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No breach of the Code was ruled.
The Panel found “simple” was used to describe the dosing regimen within the phrase “one tablet, once daily, simple”, not a general claim that Xarelto was simple to use overall.
The Panel considered the claim was not inconsistent with the SPC and did not inaccurately reflect anticoagulant risks in context.
No breach was ruled for Clauses 2, 3.2, 7.2, 7.9 and 9.1.

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