Takeda Europe Actos (pioglitazone) journal advertisement: cardiovascular safety claim ruled misleading

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Key facts

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Case number	AUTH/2125/5/08
Case reference	ACT179 (advertisement reference)
Complainant	GlaxoSmithKline UK Ltd
Respondent/company	Takeda Pharmaceuticals Europe Limited
Product(s)	Actos (pioglitazone); Avandia (rosiglitazone) (context)
Material/channel	Journal advertisement in Diabetologia (April 2008; reprinted May edition)
Key issue	Prominent CV safety claim (“no long-term cardiovascular concerns”) ruled misleading/insufficiently qualified versus SPC and lacking appropriate prominence of contraindications/warnings (heart failure/fluid retention), with patient safety concerns and Clause 2 censure context
Dates (received/completed if stated)	Complaint received 7 May 2008; Case completed 29 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 2, 3.2, 7.2, 7.9, 7.10
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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GlaxoSmithKline UK Ltd complained about an advertisement (ref ACT179) for Actos (pioglitazone) placed by Takeda Pharmaceuticals Europe Limited in Diabetologia, April 2008 (and reprinted in the May edition).
GlaxoSmithKline supplied Avandia (rosiglitazone); both pioglitazone and rosiglitazone were thiazolidinediones (TZDs).
The advertisement’s prominent claim was: “There are no long-term cardiovascular concerns regarding the use of Actos (pioglitazone)”.
GlaxoSmithKline alleged the ad omitted key safety context from the SPC, including that pioglitazone was contraindicated in patients with cardiac failure or a history of cardiac failure (NYHA stages I to IV) and that fluid retention could exacerbate or precipitate heart failure, potentially requiring additional monitoring.
GlaxoSmithKline also referenced MHRA action on a different Actos advertisement (published January 2008 by Takeda UK) which the MHRA found in breach of the Medicines (Advertising) Regulations and for which a corrective statement was requested and re-use prohibited.
The Panel considered whether the UK Code applied: Diabetologia was published in English in Germany, the editor-in-chief and editorial office were in the UK, and it circulated to UK health professionals; the Panel concluded the promotional material was subject to the UK Code.
The Panel accepted Takeda Europe as responsible under the Code because it placed the advertisement and was taking responsibility in relation to the complaint.

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The Panel ruled the prominent “no long-term cardiovascular concerns” claim was misleading and not consistent with the SPC because the SPC wording was qualified (“the results suggest…”), and because contraindications and warnings (Sections 4.3 and 4.4) took priority over Section 5.1.
The Panel considered it was not sufficient to rely on prescribing information adjacent to the advertisement to provide the cautionary note about heart failure.
The Panel ruled the claim did not reflect the entire situation and did not encourage the rational use of Actos, given risks including fluid retention potentially exacerbating/precipitating heart failure and the contraindication in patients with (or history of) heart failure.
Given MHRA concerns about similar CV-risk balance issues in earlier material and the timing (Takeda Europe had time to amend before publication), the Panel ruled a breach of Clause 2, citing concern about patient safety implications.

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Clause 3.2 – Breach ruled (advertisement not consistent with the SPC as presented; prominent claim insufficiently qualified and did not appropriately reflect contraindications/warnings).
Clause 7.2 – Breach ruled (misleading claim; did not reflect the entire situation).
Clause 7.9 – Breach ruled (misleading presentation of information such that it did not encourage rational use).
Clause 7.10 – Breach ruled (misleading presentation; did not encourage rational use).
Clause 2 – Breach ruled (material should have been amended in the circumstances; Clause 2 used as a sign of censure and reserved for such use).

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