AUTH/2357/9/10: Boehringer Ingelheim – Pradaxa ad claimed “equivalent” efficacy and safety vs enoxaparin based on non-inferiority studies | PMCPA Case

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Key facts

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Case number	AUTH/2357/9/10
Complainant	General practitioner
Company	Boehringer Ingelheim
Product	Pradaxa (dabigatran)
Material	Journal advertisement (ref DGB1729b), The Pharmaceutical Journal, 18 September 2010
Main issue	Claim of “efficacy and safety equivalent to enoxaparin” based on non-inferiority studies; balanced scales visual reinforced equivalence
Applicable Code year	2008
Complaint received	20 September 2010
Case completed	8 December 2010
Breach clauses	7.2, 7.3, 7.4, 7.9 and 7.10
No breach points	Dose not stated (not misleading in context); omission of RE-MOBILIZE (not misleading for UK prescribers); rep detail aid “comparable” wording (not misleading); Clause 2 (no breach)
Sanction	Undertaking received
Appeal	Appeal by complainant; key no-breach rulings upheld

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

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A general practitioner complained about a Boehringer Ingelheim advertisement for Pradaxa (dabigatran) published in The Pharmaceutical Journal (18 September 2010) (ref DGB1729b).
The ad used a balanced scales visual with the headline “Well balanced” and the claim: “Once-daily, oral anticoagulation Efficacy and safety equivalent to enoxaparin in primary prevention of VTE after total knee or hip replacement surgery”.
The claim was referenced to Eriksson et al (2007a) RE-NOVATE and Eriksson et al (2007b) RE-MODEL, both non-inferiority studies vs enoxaparin.
The complainant alleged that claiming “equivalent” from non-inferiority data was misleading/exaggerated/unsubstantiated and could endanger patient safety; also alleged implied superiority, misleading general safety messaging, missing enoxaparin dose, and “cherry-picking” by not citing RE-MOBILIZE.
The complaint also referred generally to sales representatives, but without specific allegations; the Authority requested the detail aid and briefing materials.
Boehringer Ingelheim accepted the ad’s “equivalent” wording was an oversight that passed the approval process and agreed it breached multiple clauses; it stated other materials used “comparable/similar”.

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Breach found for the journal advertisement’s “efficacy and safety equivalent to enoxaparin” claim (and the balanced scales presentation) as it implied unequivocal equivalence that was not shown by the cited non-inferiority studies.
Breach found because the claim did not reflect the available evidence about the safety of Pradaxa.
No breach for not stating the enoxaparin dose in the advertisement (Panel and Appeal Board: not misleading given the tightly defined licensed dose in this setting; though the Appeal Board said it was good practice to include dosage particulars).
No breach for not citing RE-MOBILIZE (Appeal Board: used an enoxaparin dose not licensed in the UK and therefore not relevant to UK prescribers; omission not misleading).
No breach regarding sales representative materials: the detail aid used “comparable”/“similar” rather than “equivalent”; the Panel and Appeal Board did not consider “comparable” implied equivalence and did not find it misleading as alleged.
No breach of Clause 2 (particular censure) – Panel and Appeal Board did not consider the circumstances warranted it.

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