Boehringer Ingelheim: Consumer press release and spokesperson briefing promoted Pradaxa for unlicensed stroke prevention (AUTH/2404/5/11)

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Key facts

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Case number	AUTH/2404/5/11
Parties	General Practitioner v Boehringer Ingelheim
Product	Pradaxa (dabigatran)
Issue	Consumer press release and spokesperson materials linked to press coverage about stroke prevention (atrial fibrillation) before the indication was licensed
Media	Daily Mail, The Telegraph, Daily Express (articles dated 5 April 2011); company press release to consumer press (ref DBG2372)
Complaint received	16 May 2011
Case completed	15 July 2011
Applicable Code year	2011
Breach clauses	2, 3.2, 9.1, 22.1 and 22.2
No breach	Clause 8.1 (disparagement of warfarin) not breached on the evidence available
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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A general practitioner complained about UK newspaper articles (Daily Mail, The Telegraph, Daily Express) on 5 April 2011 that discussed Pradaxa (dabigatran) for preventing stroke—an unlicensed indication at the time.
At that time, Pradaxa was indicated for primary prevention of venous thromboembolic events in adults after elective total hip or knee replacement surgery.
Boehringer Ingelheim had applied to the EMA to extend the licence to prevention of stroke and systemic embolism in atrial fibrillation.
The complainant alleged exaggerated claims in the press (eg “super pill”, “revolutionary drug”), likely driven by misleading company press materials and facilitated access to UK experts/patient group representatives.
The complainant also alleged warfarin was disparaged in the press as “rat poison” and that pack images of Pradaxa appeared.
Boehringer Ingelheim said the coverage arose from a single press release (ref DBG2372) reporting subgroup analyses of RE-LY; it said confidence intervals were included, the release stated the AF indication was unlicensed, it did not provide pack shots, and it did not disparage warfarin.
The Panel assessed the company’s press materials and its role in arranging spokespeople (two health professionals and two patient organisation representatives), including media briefing/training via its media agency.

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Breach found: the consumer press release and spokesperson materials were considered to encourage the public to ask a health professional to prescribe a specific prescription-only medicine and were not balanced (notably lacking side-effect information).
Breach found: advertising a prescription-only medicine to the public for an unlicensed indication.
Breach found: promotion for an unlicensed indication inconsistent with the marketing authorisation.
Breach found: high standards not maintained and conduct brought discredit upon/reduced confidence in the industry.
No breach found for disparagement of warfarin: the Panel found no evidence in the company press release of calling warfarin “rat poison” and had no evidence about what was said by spokespeople at conferences/interviews.
No appeal.

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