Bayer: Xarelto promotional email alleged to omit renal impairment warnings (AUTH/3889/4/24)

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Key facts

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Case number	AUTH/3889/4/24
Company	Bayer
Complainant	Anonymous, contactable complainant; taken up in the name of the Chief Executive (PMCPA)
Product	Xarelto (rivaroxaban)
Material	Promotional email sent by a third party on Bayer’s behalf
Audience	Verified UK general practitioners
Main allegation	No mention of contraindications/special warnings, particularly renal impairment; alleged breach of undertaking from AUTH/3035/4/18
Applicable Code	2021 ABPI Code of Practice
Clauses considered	Clauses 2, 3.3, 5.1, 6.1
Panel decision	No breach of Clauses 2, 3.3, 5.1, 6.1
Appeal	No appeal
Complaint received	16 April 2024
Case completed	8 April 2025

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

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An anonymous, contactable complainant challenged a promotional email for Xarelto (rivaroxaban) sent by a third party on Bayer’s behalf to verified UK general practitioners.
The complainant alleged the email made no mention of contraindications or special warnings, highlighting renal impairment wording from Section 4.4 of the Xarelto SmPC.
The complainant referenced an earlier case (AUTH/3035/4/18) and suggested Bayer had not learned from a previous patient-safety-related omission, implying a breach of undertaking.
Bayer said the email focused on a fictional 78-year-old patient with NVAF and diabetes, did not mention renal impairment, and linked to a promotional webpage that included renal impairment disclaimers and a link to prescribing information.
The PMCPA asked Bayer to consider Clauses 3.3, 6.1, 5.1 and 2 of the 2021 Code.

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Clause 2 – Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
Clause 3.3 – Requirement to comply with an undertaking given in relation to a ruling under the Code
Clause 5.1 – Requirement to maintain high standards at all times
Clause 6.1 – Requirement that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine

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