Jazz Pharmaceuticals UK breached ABPI Code over Epidyolex promotional video omitting key hepatic contraindication (AUTH/3918/6/24)

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Key facts

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Case number	AUTH/3918/6/24
Company	Jazz Pharmaceuticals UK
Complainant	Anonymous, contactable health professional (later non-contactable)
Product	Epidyolex (cannabidiol)
Material type	Promotional video presentation (39 minutes 35 seconds) aimed at UK health professionals
Main issue	Hepatic monitoring/dosing content omitted the SmPC contraindication (transaminases >3x ULN and bilirubin >2x ULN) in key slides/sections, creating a misleading impression
Applicable Code	2021
Complaint received	02 June 2024
Case completed	19 May 2025
Appeal	No appeal
Breach clauses	Clause 2; Clause 5.1; Clause 6.1 (x2)
No breach clauses	Clause 6.1; Clause 6.2
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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An anonymous (later non-contactable) health professional complained about a 39m 35s Jazz-funded promotional video for UK health professionals about Epidyolex (cannabidiol), featuring three speakers and patient case studies.
The complaint focused on hepatic monitoring content early in the video (around 20–29 seconds) and the absence of a specific SmPC contraindication: patients with transaminase elevations >3x ULN and bilirubin >2x ULN should not be given Epidyolex.
The complainant also alleged two speaker sections using case studies did not mention this contraindication when discussing initiation/continuation.
A further allegation challenged a summary claim that Epidyolex had a “manageable safety profile”, arguing pneumonia and hepatic enzyme elevations would require withdrawal.
Jazz responded that safety content and prescribing information were included (including the contraindication within prescribing information), and argued not every contraindication needed to be repeated in the case studies; it also argued the “manageable safety profile” statement was consistent with the SmPC.

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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 (x2) Making a misleading claim
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation

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Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 Failing to maintain high standards
Clause 6.1 (x2) Making a misleading claim
Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading (No breach)
Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation (No breach)

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