AstraZeneca breach over Trixeo ad implying mortality benefit (Pulse magazine)

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Key facts

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Case	AUTH/3709/11/22
Complainant	Health professional
Company	AstraZeneca
Product	Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide)
Material	Print advertisement in Pulse magazine (October 2022); prescribing information and adverse event reporting details on reverse
Main issue	Ad created a misleading, unsubstantiated implication that Trixeo had a positive effect on mortality (death), due to proximity of “death” statement and “Take action with Trixeo” message
Applicable Code year	2021
Breach clauses	5.1, 6.1, 6.2, 14.4
No breach clauses	11.2
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	16 November 2022
Case completed	20 October 2023
Appeal	No appeal

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

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A health professional complained about a Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide) print advertisement in the October 2022 edition of Pulse magazine (aimed at GPs).
The ad headline stated: “Just one moderate COPD exacerbation can put your patient in hospital and even cause death”.
Immediately below, the ad positioned the product for “uncontrolled COPD patients on dual therapy*” and used a prominent call-to-action: “Take action with Trixeo”.
The complainant alleged readers would link the death statement to the call-to-action and infer triple therapy would reduce deaths, which they said was not supported by Phase 3 data (mortality being a secondary outcome).
The Panel considered the overall impression of the single-page A4-style ad (including imagery of a dragon breathing fire linking the two messages) and how readers might interpret it.

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Breach: Clause 5.1 Failing to maintain high standards.
Breach: Clause 6.1 Making a misleading claim.
Breach: Clause 6.2 Making an unsubstantiated claim.
Breach: Clause 14.4 Not encouraging the rational use of the medicine.
No breach: Clause 11.2 Requirement not to promote a medicine for an unlicensed indication.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 14.4 Not encouraging the rational use of the medicine
No Breach of Clause 11.2 Requirement not to promote a medicine for an unlicensed indication

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