AUTH/2224/4/09: Professor of Cardiology v Merck Sharp & Dohme (Cozaar) — No breach (journal ad and beta‑blocker caution) | PMCPA Case

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Key facts

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Case number	AUTH/2224/4/09
Company	Merck Sharp & Dohme Limited
Complainant	Professor of cardiology
Product	Cozaar (losartan)
Material	Journal advertisement headed “Cozaar: The facts” (ref 03-10CZR.09.GB.10159.Jc), appeared inter alia in the BMJ
Main issue	Whether the ad sufficiently referenced SPC warnings about concomitant beta-blocker use in heart failure and whether it was misleading/dangerous
Clauses considered	2, 3.2, 7.2 and 9.1
Decision	No breach of the Code
Complaint received	15 April 2009
Case completed	22 May 2009
Applicable Code year	2008
Appeal	No appeal

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

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A professor of cardiology complained about a Cozaar (losartan) journal advertisement by Merck Sharp & Dohme, headed “Cozaar: The facts”, which appeared (inter alia) in the BMJ.
The complainant alleged the ad did not adequately refer to warnings about use of losartan in chronic heart failure patients who were also on a beta-blocker.
The complainant said the ad strongly implied losartan was widely indicated for patients aged ≥60 with chronic heart failure where ACE inhibitors were unsuitable, without highlighting key SPC warnings.
The complainant cited SPC statements: “The combination of losartan with a beta-blocker should be used with caution” (Section 4.4) and “An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline” (Section 5.1).
Merck Sharp & Dohme stated the ad’s purpose was to compare licensed indications across angiotensin-II antagonists and that the ad’s prescribing information included, under heart failure, “Use with caution in… combination with a beta-blocker”.

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No breach of the Code was ruled.
The Panel found the advertisement was not inconsistent with the Cozaar SPC and did not consider it dangerous or misleading as alleged.
No breach was ruled for Clauses 3.2, 7.2, 9.1 and 2.

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