Novartis breached Code over Mayzent web page implying initiation was suitable for patients with recent MI/heart failure (AUTH/3655/6/22)

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Key facts

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Case	AUTH/3655/6/22
Complainant	Anonymous health professional
Company	Novartis
Medicine	Mayzent (siponimod)
Channel/material	Novartis website page: ‘Dosing and administration’ (www.health.novartis.co.uk)
Main issue	Reference to initiation/ECG monitoring for patients with history of myocardial infarction or heart failure without making clear the absolute contraindication for patients with MI/heart failure in the previous 6 months
Applicable Code year	2021
Complaint received	6 June 2022
Case completed	27 June 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 6.2; Clause 5.1; Clause 2
No breach (separate issue: pregnancy section)	Clause 6.1; Clause 6.2; Clause 5.1; Clause 2
Sanctions applied	Undertaking received; Advertisement

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

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An anonymous health professional complained about the ‘Dosing and administration’ page for Mayzent (siponimod) on www.health.novartis.co.uk (UK | January 2021 | 104535).
The page’s ‘Additional tests for at risk patients’ box stated: “Perform vitals and baseline ECG for patients with… a history of myocardial infarction or heart failure” and advised 6-hour monitoring and a second ECG.
The complainant alleged this was misleading because Mayzent was contraindicated in certain cardiac patients, including those who in the previous 6 months had myocardial infarction or decompensated heart failure (requiring inpatient treatment) or NYHA class III/IV heart failure (per SPC Section 4.3).
The complainant also alleged it was misleading to highlight pregnancy contraindication in small writing without listing other contraindications on that section of the page.
Novartis argued the information was taken from the SPC, that prescribing information was linked on every page, and that contraindications were available on other pages (Safety page and Risk Management Materials/prescriber checklist).

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Breach found for the cardiac initiation content: the Panel considered the page gave an immediate misleading impression that Mayzent could be initiated in patients with a recent (within 6 months) history of myocardial infarction or heart failure, because the absolute contraindication for the previous 6 months was not made apparent on that page/section.
No breach found regarding the pregnancy section: highlighting pregnancy contraindication did not mean health professionals would assume there were no other contraindications.
The Panel emphasised that each webpage should be capable of standing alone for Code requirements.

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Breach of Clause 6.1 Providing misleading information
Breach of Clause 6.2 Providing a misleading impression which was incapable of substantiation
Breach of Clause 5.1 Failure to maintain high standards
Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
No Breach of Clause 6.1 Requirement that claims must not be misleading
No Breach of Clause 6.2 Requirement that claims must be capable of substantiation
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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