AUTH/3770/5/23: Daiichi Sankyo – Nustendi website omitted a key contraindication on tolerability page

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Key facts

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Case	AUTH/3770/5/23
Company	Daiichi Sankyo UK Ltd
Product	Nustendi (bempedoic acid and ezetimibe); website also referenced Nilemdo (bempedoic acid)
Material	Promotional website (job code BEM/22/0035, certified September 2022)
Main issue	Omission of contraindication: Nustendi coadministered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases (missing from tolerability page contraindications list)
Pages assessed	Homepage; Efficacy page; Tolerability page
Applicable Code	2021
Complaint received	29 May 2023
Case completed	9 July 2024
Appeal	No appeal
Company response highlights	Acknowledged omission on tolerability page due to oversight; managed via deviation process; website taken down; accepted breaches of Clauses 6.1, 6.2, 5.1 for that page; disputed Clause 2
Panel findings	No breach for homepage and efficacy page; breach of Clauses 6.1, 6.2, 5.1 and 2 for tolerability page
Sanctions applied	Undertaking received; additional sanctions not stated; advertisement not stated

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

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An anonymous complainant alleged that a Nilemdo/Nustendi promotional website suggested Nustendi could be added to statins without stating a key contraindication from the Nustendi SmPC.
The contraindication at issue: Nustendi coadministered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
Three webpages were cited: Home, Efficacy and Tolerability (website job code BEM/22/0035, certified September 2022).
Daiichi Sankyo stated the contraindication was missing from the tolerability page due to an oversight during the approval process and said the website had been taken down.
The Panel assessed each page separately and focused on the overall impression to a health professional, including whether pages could “stand alone” without relying on prescribing information elsewhere.

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.1 Providing misleading information
Breach of Clause 6.2 Providing misleading information that was incapable of substantiation
No Breach of Clause 2 (x2) Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 (x2) Requirement to maintain high standards
No Breach of Clause 6.1 (x2) Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2 (x2) Requirement that claims/information/comparisons must be capable of substantiation

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