Takeda misleadingly implied generic losartan was a black triangle medicine in ARB heart failure ad (AUTH/2367/10/10)

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Key facts

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Case number	AUTH/2367/10/10
Complainant	A general practitioner and GP prescribing lead
Company	Takeda UK Ltd
Material	Two-page advertisement (ref TA101054) for Amias (candesartan) in Guidelines in Practice, October 2010
Issue	Black triangle symbol placed next to “losartan”, implying all losartan (including generics) was a black triangle medicine; clarification referenced overleaf
Applicable Code year	2008
Complaint received	27 October 2010
Case completed	06 April 2011
Breach clauses	Clause 7.2
No breach clauses	Clause 6.1; Clause 5.7; Clause 4.1
Clause 4.11	Not ruled on
Sanctions	Undertaking received; additional sanctions not stated
Appeal	Appeal by respondent (Takeda) unsuccessful; breach upheld

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

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A general practitioner and GP prescribing lead complained about a two-page advertisement for Amias (candesartan) by Takeda in Guidelines in Practice (October 2010).
The ad compared candesartan, losartan and valsartan for chronic heart failure using a table of “clinical attributes”.
The table indicated losartan and valsartan were “black triangle” medicines (subject to special reporting requirements), while candesartan was not.
The complainant alleged the first page was misleading because it placed a black triangle next to the generic name “losartan”, even though generic losartan did not carry a black triangle warning in the BNF (whereas branded losartan, Cozaar, did).
The clarification that the black triangle related to the Cozaar SPC appeared on the second page (overleaf) via an asterisk/footnote reference.
Takeda argued the black triangle related to the active substance and was reinstated for losartan/valsartan in heart failure, and that patient safety supported encouraging reporting regardless of whether branded or generic was dispensed.

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Breach found: The implication that all forms of losartan were black triangle medicines was misleading.
Appeal: Takeda appealed the Clause 7.2 ruling; the Appeal Board upheld the breach.
No breach findings: No breach of Clause 6.1; no breach of Clause 5.7; no breach of Clause 4.1.
The Appeal Board asked the PMCPA to inform the MHRA and the ABPI regulatory expert network and request urgent clarification on the black triangle position for generics vs brands.

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