AstraZeneca breached ABPI Code over Forxiga “start on 10mg” dosing claims hidden behind footnote (AUTH/3618/3/22)

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Key facts

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Case	AUTH/3618/3/22
Company	AstraZeneca
Product	Forxiga (dapagliflozin)
Issue	Dosing claims implying all patients can start 10mg (and “start today”) while the 5mg severe hepatic impairment start was only in a small footnote
Channel	Promotional website (forxiga.co.uk) and representative discussion
Material reference	GB-34486
Complaint received	11 March 2022
Case completed	3 April 2023
Applicable Code	2021
Breach clauses	2, 5.1, 6.1, 6.2, 11.2, 14.4
No breach clauses	6.2, 17.9
Appeal	No appeal
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 Forxiga (dapagliflozin) promotion by AstraZeneca.
The complaint related to (1) a call with an AstraZeneca representative and (2) claims on the promotional website forxiga.co.uk (material ref GB-34486; screenshot taken March 2022).
The website included prominent claims: “FORXIGA 10mg. Simple once-daily dosing – start on 10mg, stay on 10mg, no need for uptitration*” and “Start FORXIGA 10mg today”.
Important qualifying safety information—“In patients with severe hepatic impairment, a starting dose of 5mg is recommended. If well tolerated, the dose may be increased to 10mg.”—appeared only as a small footnote that could easily be missed.
The complainant also challenged a renal claim (“For cardiorenal benefits, initiate in patients with eGFR ≥15mL/min/1.73m²**”) given a footnote stating limited experience initiating in patients with eGFR <25.
AstraZeneca argued the dosing and eGFR claims were consistent with the SPC, that the 5mg hepatic impairment information was clearly stated, and that representatives were fully briefed and tested on the SPC.

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Breach findings were made for the two dosing “start 10mg” claims on the website because the qualifying 5mg start for severe hepatic impairment was not sufficiently prominent and the claims did not stand alone.
No breach was found for the allegation that the eGFR initiation claim was incapable of substantiation.
No breach was found for the allegation about representatives’ briefing material (on the narrow allegation and limited evidence available).
No appeal.

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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 which was not capable of substantiation
Breach of Clause 11.2 Promotion inconsistent with the summary of product characteristics
Breach of Clause 14.4 Not encouraging the rational use of a medicine
No Breach of Clause 6.2 Requirement that information, claims or comparisons must be capable of substantiation
No Breach of Clause 17.9 Requirement that representatives’ briefing material must comply with the relevant requirements of the Code

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