AstraZeneca Forxiga website renal considerations complaint (AUTH/3782/6/23): no breach

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Key facts

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Case number	AUTH/3782/6/23
Company	AstraZeneca UK Limited
Complainant	Anonymous; described themselves as a health professional
Product	Forxiga (dapagliflozin)
Material/channel	Promotional website; “Prescribing & Dosing” webpage (including “What renal considerations are there with FORXIGA?”)
Main allegation	Misleading omission: page did not include SPC 4.4 statement that in moderate renal impairment (eGFR <60 mL/min/1.73m²) there was a higher proportion of adverse reactions of increased PTH and hypotension vs placebo; alleged “cherry-picking” and patient safety risk
Applicable Code	2021
Clauses considered	2, 5.1, 6.1, 6.2
Panel decision	No breach of Clauses 2, 5.1, 6.1, 6.2
Complaint received	22 June 2023
Case completed	8 March 2024
Appeal	No appeal

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

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An anonymous health professional complained about AstraZeneca’s promotional website for Forxiga (dapagliflozin), specifically the “Prescribing & Dosing” webpage.
The complaint focused on the expandable section “What renal considerations are there with FORXIGA?” and alleged it was misleading by omission.
The complainant said the page did not include SPC section 4.4 wording that in patients with moderate renal impairment (eGFR <60 mL/min/1.73m²), a higher proportion of patients treated with dapagliflozin had adverse reactions of increased parathyroid hormone (PTH) and hypotension vs placebo.
The complainant alleged the safety information was “cherry-picked”, creating a patient safety risk, and cited Clauses 6.1, 6.2, 5.1 and 2.
AstraZeneca responded that the page was about practical prescribing/dosing; the SPC required no dose adjustment, no special monitoring, and no patient selection changes for moderate renal impairment; and the site directed readers to prescribing information/SPC and included a separate section on hypotension/hypovolaemia risk.

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Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
Clause 5.1 Requirement to maintain high standards at all times
Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
Clause 6.2 Requirement that information/claims/comparisons must be capable of substantiation

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