Daiichi Sankyo breached Code over SMC summary card: simvastatin contraindication not immediately apparent (AUTH/3649/5/22)

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Key facts

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Case	AUTH/3649/5/22
Complainant	Anonymous health professional
Company	Daiichi Sankyo
Material	SMC Guidelines summary card (electronic), 4 pages; Job code BEM/21/0732; Date of prep December 2021
Products	Nilemdo (bempedoic acid); Nustendi (bempedoic acid and ezetimibe)
Main issue	Body text referred to use in combination with a statin but did not make immediately apparent the contraindication with concomitant simvastatin >40mg daily
Related prior case	AUTH/3504/4/21 (undertaking signed 6 December 2021)
Applicable Code year	2021
Complaint received	14 February 2022
Case completed	23 February 2023
Appeal	No appeal
Breach clauses	Clause 2; Clause 3.3; Clause 5.1; Clause 6.1
No breach clauses	Clause 6.1; Clause 6.2
Sanctions	Undertaking received; Advertisement

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

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An anonymous health professional complained about a 4-page electronic SMC guidelines summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) (Job code BEM/21/0732, prepared December 2021), commissioned and funded by Daiichi Sankyo UK.
Pages 1–2 summarised SMC advice and included an “Indication under review” section stating use in combination with a statin.
The complainant alleged the card was misleading because it did not state next to those “with a statin” statements that both products are contraindicated with concomitant simvastatin >40mg daily.
The complainant also raised that Nustendi has an additional contraindication when co-administered with a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases, and said this was not mentioned on pages 1–2.
The complainant alleged the issue repeated a previous finding and therefore breached an undertaking given in Case AUTH/3504/4/21.
Daiichi Sankyo argued the wording was taken directly from SMC advice, and that contraindications were included in the prescribing information on pages 3–4, signposted from pages 1–2.

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Breach: The card failed to make immediately apparent in the body of the promotional material that Nilemdo/Nustendi are contraindicated with simvastatin >40mg daily when the material referred to use in combination with a statin.
Breach: Daiichi Sankyo failed to comply with an undertaking given in AUTH/3504/4/21 on the same issue.
No breach: The complainant did not establish that omission (from the body text) of Nustendi’s liver-related contraindication made the material misleading, given the material did not imply there were no liver disease considerations and the contraindication appeared in prescribing information.
No breach: The complainant did not establish the material was incapable of substantiation.
No appeal.

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Breach of Clause 3.3 Failure to comply with an undertaking
Breach of Clause 6.1 Misleading impression provided
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

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