Jazz Pharmaceuticals: Epidyolex HCP videos ruled misleading due to omitted hepatic contraindication and dose adjustment/discontinuation guidance (AUTH/3917/6/24)

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Key facts

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Case number	AUTH/3917/6/24
Company	Jazz Pharmaceuticals
Product	Epidyolex (cannabidiol)
Materials	Two online presentations for health professionals: (1) “Understanding the Pharmacology of Epidyolex (cannabidiol)” (2) “Optimise the Clinical Use of Epidyolex (cannabidiol)”
Audience	UK health professionals (physicians, nurses, pharmacists) (as described by Jazz)
Main issue	Omission of key SPC safety information (hepatic contraindication and dose reduction/discontinuation guidance) leading to misleading impressions and inadequate speaker briefing
Applicable Code year	2021
Complaint received	01 June 2024
Case completed	19 May 2025
Appeal	No appeal
Breach clauses	Clause 2; Clause 5.1 (x3); Clause 6.1 (x3)
No breach clauses	Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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An anonymous, contactable health professional complained about two Jazz-funded online presentations for UK health professionals about Epidyolex (cannabidiol).
Video 1 (“Understanding the Pharmacology of Epidyolex”) discussed concomitant CBD and valproate but did not include any reference to dose adjustment and/or discontinuation in relation to this combination.
Video 2 (“Optimise the Clinical Use of Epidyolex”) included dosing/monitoring slides but did not explicitly include the SPC hepatic contraindication threshold (transaminases >3x ULN and bilirubin >2x ULN).
In Video 2’s case-study section, a warning box discussed increased incidence of transaminase elevations with valproate and monitoring, but did not include dose reduction/discontinuation guidance; the slide also stated “No safety concerns” (other than drowsiness).
The complainant also alleged the speakers were not appropriately briefed on these safety points.

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1 (x3) Failing to maintain high standards
Breach of Clause 6.1 (x3) Making a misleading claim
No Breach of Clause 9.1 Requirement that all relevant personnel concerned with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations

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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 Making a misleading claim
Clause 9.1 Requirement that all relevant personnel concerned with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations

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