GSK v Takeda Europe: Actos (pioglitazone) Diabetologia ad and cardiovascular safety claims

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Key facts

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Case number	AUTH/2125/5/08
Case reference	Actos journal advertisement in Diabetologia (ref ACT179)
Complainant	GlaxoSmithKline UK Ltd
Respondent/company	Takeda Pharmaceuticals Europe Limited
Product(s)	Actos (pioglitazone)
Material/channel	Journal advertisement in Diabetologia (April 2008; reprinted May edition)
Key issue	Prominent claim “There are no long-term cardiovascular concerns” considered misleading and insufficiently qualified versus SPC; inadequate prominence of heart failure contraindication/warnings; patient safety concerns and failure to amend after MHRA action on related advertising
Dates (received/completed if stated)	Complaint received 7 May 2008; Case completed 29 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 2; Clause 3.2; Clause 7.2; Clause 7.9; Clause 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 products were thiazolidinediones (TZDs).
The advertisement’s prominent claim was: “There are no long-term cardiovascular concerns regarding the use of Actos (pioglitazone)”.
GSK alleged the ad did not mention that Actos was contraindicated in patients with cardiac failure or a history of cardiac failure (NYHA stages I to IV) and that pioglitazone could cause fluid retention which might exacerbate or precipitate heart failure (per SPC), potentially requiring additional monitoring.
GSK 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 considered responsibility: Takeda Europe had placed the advertisement and accepted responsibility under the Code; the Panel accepted this for handling the complaint.

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The Panel ruled the prominent claim was not consistent with the SPC wording because the SPC stated the results “suggest” there are no long-term cardiovascular concerns, and also noted increased incidences of oedema, weight gain and heart failure.
The Panel stated that SPC section 5.1 did not take priority over sections 4.3 (contraindications) and 4.4 (warnings/precautions) regarding heart failure and fluid retention.
The Panel considered it was not sufficient to rely on adjacent prescribing information to provide the cautionary note about heart failure.
The Panel ruled the claim was misleading, did not reflect the entire situation, and did not encourage the rational use of Actos.
Given the timing after MHRA action on another Actos advertisement and that Takeda Europe had time to amend the Diabetologia material, the Panel ruled a breach of Clause 2, noting patient safety implications and that Clause 2 was used as a sign of censure and reserved for such use.

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Clause 2 (bringing discredit upon, and reducing confidence in, the industry): Breach ruled (used as a sign of censure and reserved for such use).
Clause 3.2 (promotion must be in accordance with marketing authorisation/SPC): Breach ruled.
Clause 7.2 (claims must be accurate, balanced, fair, objective and unambiguous): Breach ruled.
Clause 7.9 (claims must not be misleading by distortion, exaggeration, undue emphasis, omission, etc): Breach ruled.
Clause 7.10 (claims must be capable of substantiation): Breach ruled.

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