Boehringer Ingelheim breached ABPI Code over Pradaxa 110mg website claim implying use in “any patient at increased risk of bleeding” (AUTH/3293/1/20)

📊

Key facts

⌄

Case	AUTH/3293/1/20
Complainant	Anonymous (health professional)
Company	Boehringer Ingelheim Limited
Medicine	Pradaxa (dabigatran); claim related to Pradaxa 110mg
Channel/material	Website landing page for Pradaxa 110mg (ref PC-UK-101787 V1)
Key claim	“Pradaxa 110 is the only low-dose [novel oral anticoagulant] for stroke prevention in atrial fibrillation recommended for use in any patient at increased risk of bleeding*”
Panel concern	Claim implied use in all increased-bleeding-risk patients despite contraindication in severe renal impairment (CrCl <30 mL/min); footnote/link did not cure the issue
Breach clauses	2, 7.2, 9.1
Sanctions	Undertaking received; Advertisement
Complaint received	30 December 2019
Case completed	18 December 2020
Applicable Code year	2019
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous health professional complained about promotion of Pradaxa (dabigatran) by Boehringer Ingelheim Limited.
The complaint focused on the claim: “recommended for use in any patient at increased risk of bleeding”.
The complainant argued the claim could not be substantiated because Pradaxa is contraindicated in severe renal impairment (CrCl <30 mL/min), which may be relevant in elderly patients.
The complainant did not provide the material or context and could not be contacted for follow-up.
Boehringer Ingelheim provided the Pradaxa 110mg website landing page (ref PC-UK-101787 V1) that it said was current when the complaint was submitted (30 December 2019); the Panel based its rulings on this page.
The landing page stated: “Pradaxa 110 is the only low-dose [novel oral anticoagulant] for stroke prevention in atrial fibrillation recommended for use in any patient at increased risk of bleeding*”.
A small-font link (“See how to select the right dose of Pradaxa”) and a small-font footnote (“Pradaxa 110 is also recommended for patients over 80 years of age and patients currently treated with verapamil”) appeared beneath/alongside the claim.

⚖️

⌄

The Panel ruled the claim was misleading because a busy health professional could interpret it as meaning Pradaxa 110mg could be prescribed to all patients at increased risk of bleeding, despite contraindication in severe renal impairment.
The Panel stated it was irrelevant that a link to further information existed; claims must be capable of standing alone without recourse to footnotes/links.
The Panel noted concern about referencing “over 80s” in the footnote given renal impairment risk increases with age.
Breaches were ruled under Clauses 7.2, 9.1 and 2.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access