AstraZeneca Trixeo eligibility checklist: narrow-angle glaucoma counselling text omitted (no breach on appeal)

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Key facts

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Case number	AUTH/3777/6/23
Company	AstraZeneca
Complainant	Anonymous, contactable complainant (self-described health professional)
Material	Trixeo “patient eligibility checklist” (interactive PDF) hosted on Trixeo website resources section (UK HCP promotional website)
Medicine	Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide)
Main issue	Whether omission of SmPC counselling/stop-treatment text about acute narrow-angle glaucoma from Q11 response made the checklist misleading
Applicable Code year	2021
Complaint received	12 June 2023
Case completed	19 September 2024
Panel outcome	Breach of Clauses 6.1, 5.1 and 2; no breach of 6.2 (later appealed)
Appeal outcome	No breach of Clauses 6.1, 5.1 and 2; no breach of 6.2
Final outcome	No breach of the Code
Appeal hearing	Respondent appeal

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

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An anonymous, contactable complainant (self-described health professional) challenged a UK HCP promotional website resource: a Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide) “patient eligibility checklist”.
The checklist was an interactive PDF with 13 questions; question 11 asked whether the patient had symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma.
If the user answered “Yes” to Q11, the checklist displayed: “Due to its anticholinergic activity, TRIXEO should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma.”
The complainant alleged the checklist was misleading because it omitted additional SmPC section 4.4 text for narrow-angle glaucoma: “Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop.”
The Panel initially ruled the omission (plus the overall impression and lack of clear direction to consult the SmPC) made the checklist misleading and raised patient safety concerns.
AstraZeneca appealed the Panel’s rulings on Clauses 6.1, 5.1 and 2.
At appeal, AstraZeneca representatives advised that the answer to Q11 did not affect the checklist outcome (users proceeded to Q12 regardless of yes/no).

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Clause 2 – Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry.
Clause 5.1 – Requirement to maintain high standards at all times.
Clause 6.1 – Requirement that information, claims and comparisons must not be misleading.
Clause 6.2 – Requirement that information, claims and comparisons must be capable of substantiation.

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