Bayer breached ABPI Code over ambiguous Xarelto renal impairment claim implying use “with confidence”

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Key facts

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Case number	AUTH/3035/4/18
Complainant	Anonymous health professional
Company	Bayer
Product	Xarelto (rivaroxaban)
Material	Advertisement in Pulse (April 2018), ref UKXAR01180037d
Main issue	Ambiguous claim “In your patients with renal impairment” alongside “with confidence” headline implied broad confident use despite SPC cautions/limitations
Applicable Code year	2016
Complaint received	26 April 2018
Case completed	8 October 2018
Appeal	No appeal
Breach clauses	2; 7.2; 7.4; 9.1
Clause 7.9	Raised, but no ruling made
Sanctions	Undertaking received; Advertisement

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

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An anonymous UK health professional complained about a Bayer Xarelto (rivaroxaban) advertisement (ref UKXAR01180037d) placed in Pulse, April 2018.
Headline claim: “Xarelto Protects Your High-Risk NVAF Patients with Confidence”.
A bullet point stated: “In your patients with renal impairment”.
The complainant cited the SPC wording for severe renal impairment (CrCl 15–29 ml/min): limited clinical data, increased plasma concentrations, “to be used with caution”; and “use is not recommended” for CrCl <15 ml/min.
Bayer argued “confidence” referred to efficacy (stroke prevention) and that a small-font footnote referenced dose reduction and caution in CrCl 15–29 ml/min; Bayer also said “renal impairment” was intended to cover mainly mild-to-moderate impairment.
Bayer acknowledged possible ambiguity, accepted a breach of Clause 7.2, withdrew the advertisement and related materials, and amended future materials.

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The Panel ruled the claim “In your patients with renal impairment”, read with the headline, implied Xarelto could be used with confidence in all NVAF patients with renal impairment, which was not the case.
The small-font footnote did not negate the misleading overall impression.
The claim was found misleading and not capable of substantiation.
The Panel considered the claim could potentially put patient safety at risk (particularly severe renal impairment and CrCl <15 ml/min) and therefore brought discredit upon the industry.
No ruling was made under Clause 7.9 (raised, but the Panel did not consider there was an allegation in that regard).

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