AUTH/3109/10/18: AstraZeneca website – Forxiga, Onglyza and Symbicort claims (misleading comparisons and undue emphasis) | PMCPA Case

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Key facts

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Case number	AUTH/3109/10/18
Company	AstraZeneca UK Limited
Material	AstraZeneca HCP medicines website pages
Products	Forxiga (dapagliflozin); Onglyza (saxagliptin); Symbicort (budesonide/formoterol)
Complaint received	29 October 2018
Case completed	5 July 2019
Applicable Code year	2016
Appeal	No appeal
Key issues	Misleading comparative presentation; undue emphasis on relative effects; balance of primary vs secondary endpoints; prominence of absolute vs relative data; completeness of response to the Authority
Breach clauses	7.2; 7.3; 9.1
No breach areas (high level)	Forxiga weight/BP context; Symbicort asthma pages (based on narrow allegations)
Sanction	Undertaking received
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth31091018-complainant-v-astrazeneca

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

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A UK health professional complained about AstraZeneca UK’s HCP medicines website pages for Forxiga (dapagliflozin), Onglyza (saxagliptin) and Symbicort (budesonide/formoterol).
Forxiga: complaint alleged the site gave significant space to weight loss and blood pressure reduction (said to be unlicensed indications).
Onglyza: complaint alleged a graphic under “Onglyza vs SU” misrepresented the HbA1c difference vs sulphonylurea by making “-0.74%” look like the between-group difference (actual between-group difference stated as 0.06% in small text).
Symbicort (COPD): complaint alleged relative reductions were displayed far more prominently than absolute rates and that a prominent “83% improvement” appeared to ignore a non-significant endpoint.
Symbicort (asthma): complaint alleged “39% reduction” lacked clear absolute levels and “7x more asthma control days” was hard to see as vs baseline rather than vs comparator.
AstraZeneca said the website was intended for UK health professionals and removed access to the pages while awaiting the Panel’s rulings.
The Panel also expressed concern that AstraZeneca only provided the full Forxiga website content after a request, noting self-regulation relies on full and accurate responses.

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Forxiga: No breach. References to weight/BP reductions were considered acceptable in context (with prominent statements that Forxiga was not indicated for weight loss or BP management, and positioned after HbA1c data).
Onglyza: Breach. The layout created an immediate misleading impression that “-0.74%” was the difference vs sulphonylurea; the true between-group difference (0.06%) was not prominent enough.
Symbicort (COPD): Breach on both pages reviewed:
- Exacerbation reduction: undue emphasis on “23% relative risk reduction” vs formoterol; absolute rates and the non-significant co-primary endpoint were not presented with sufficient balance/prominence.
- Symptom control: undue emphasis on “83% relative improvement” in a secondary endpoint (CDLM) despite a non-significant primary endpoint; absolute change and clinical relevance were not presented with proportionate emphasis.
Symbicort (asthma): No breach (based on the narrow allegations). The Panel considered the absolute figures were stated for the 39% claim and it was sufficiently clear that “7x more asthma control days” was vs baseline.

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