AstraZeneca fined for misleading Seroquel ‘favourable weight profile’ claim (AUTH/2294/1/10, AUTH/2296/1/10, AUTH/2297/1/10)

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Key facts

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Company	AstraZeneca
Medicine / therapy area	Seroquel (quetiapine) / antipsychotic
Cases	AUTH/2294/1/10; AUTH/2296/1/10; AUTH/2297/1/10
Complainants	Journalist; member of the public; ex-employee
Material	Journal advertisement in the British Journal of Psychiatry (April 2004); BBC online news item and Radio 4 File on 4 referenced (review focused on UK ad)
Main issue	Claim implying Seroquel had a uniquely “favourable weight profile” across the dose range, potentially implying no weight gain or clear advantage vs other atypicals
Applicable Code	2003
Complaint received	26 January 2010 (AUTH/2294/1/10; AUTH/2296/1/10); 27 January 2010 (AUTH/2297/1/10)
Completed	12 March 2010 (AUTH/2294/1/10; AUTH/2296/1/10); 19 May 2010 (AUTH/2297/1/10)
Breach findings	Clauses 7.2, 7.4, 7.9 (misleading/unsubstantiated); Clause 9.1 (high standards) in AUTH/2296/1/10; No breach of Clause 2
Appeal	Complainant appeal on Clause 2 (AUTH/2297/1/10) unsuccessful; no breach of Clause 2 upheld
Sanctions	Undertaking received; additional sanctions not stated

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

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Three complaints were made about AstraZeneca’s UK promotion of Seroquel (quetiapine).
A 2004 British Journal of Psychiatry advertisement stated: “The only atypical with placebo level EPS (including akathisia) and placebo level prolactin concentrations and a favourable weight profile across the full dose range”.
A journalist alleged the ad effectively claimed “no weight gain”.
A member of the public asked PMCPA to review a BBC online news item (26 Jan 2010) alleging a former medical adviser was pressured to approve claims that weight gain was not an issue.
An ex-employee referenced a BBC Radio 4 File on 4 programme and US media articles; PMCPA limited its assessment to UK material (the 2004 UK ad).
The Panel considered the phrase “favourable weight profile” was undefined and could lead readers to assume Seroquel had no effect on bodyweight or a clear advantage vs other atypical antipsychotics.
The Panel reviewed evidence including published studies and the SPC, noting weight gain occurred with Seroquel and was listed as a common adverse event in the relevant SPC.

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AUTH/2294/1/10: Breach of Clauses 7.2, 7.4 and 7.9 (2003 Code) for a misleading and unsubstantiated claim about weight profile.
AUTH/2296/1/10: Breach of Clauses 7.2, 7.4 and 7.9 (as above) and breach of Clause 9.1 (high standards not maintained). No breach of Clause 2.
AUTH/2297/1/10 (appeal by complainant): Appeal against “no breach of Clause 2” was unsuccessful; Appeal Board upheld no breach of Clause 2.
AstraZeneca accepted the Panel’s rulings (as recorded in the case material).

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