PMCPA Case
| Case number | AUTH/2456/11/11 |
| Complainant | General practitioner |
| Company | Boehringer Ingelheim Limited |
| Product | Pradaxa (dabigatran) |
| Channel | Third-party website (www.doctors.net.uk); e-promotion |
| Key allegations | Relative risk presented without absolute risk; prescribing information omitted in connection with linked reprints; misleading omission regarding 75mg strength for AF indication |
| Materials referenced | Clinical paper summary βDabigatran versus warfarin in patients with atrial fibrillationβ (DBG2430); webpage βPradaxa β stroke prevention in atrial fibrillationβ (DBG2686); hyperlinks to Connolly et al (2009, 2010) |
| Authority focus | Clauses 4.1 and 7.2; supplementary information to Clause 10.1 |
| Applicable Code year | 2011 |
| Panel decision | No breach of the Code |
| Complaint received | 15 November 2011 |
| Case completed | 2 February 2012 |
| Appeal | No appeal |
Download the full case report (PDF)
Reviewed by Dr Anzal Qurbain (FFPM) β ABPI Final Signatory
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