Boehringer Ingelheim: Pradaxa HCP website dosing flowchart found misleading due to poorly signposted renal contraindication (AUTH/3462/1/21)

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Key facts

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Case	AUTH/3462/1/21
Complainant	Independent Appeal Board Member (in capacity as a health professional)
Company	Boehringer Ingelheim Limited
Product	Pradaxa (dabigatran etexilate)
Material	Pradaxa HCP website homepage/“Information for Health Professionals” section; “Simple, physician-directed dosing” flowchart
Main issue	Contraindication (CrCl <30 mL/min) not clearly brought to attention; appeared footnote-like and separated by prominent CTA
Applicable Code year	2019
Complaint received	27 January 2021
Case completed	3 August 2021
Appeal	No appeal
No breach	Clause 7.2 (re: not prompting bleeding-risk consideration in over-80s)
Breach	Clause 2; Clause 7.2; Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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An independent member of the Code of Practice Appeal Board (acting as a health professional) complained about the Pradaxa (dabigatran) HCP website (pradaxa.co.uk) regarding NVAF stroke prevention dosing content.
The page included a “Simple, physician-directed dosing” flowchart recommending 110mg or 150mg twice daily based on age (≥80), concomitant verapamil, and bleeding risk.
The complainant alleged the flowchart did not clearly state that Pradaxa was contraindicated in severe renal impairment (CrCl <30 mL/min) and did not prompt consideration of bleeding risk in the over-80s.
The renal contraindication and renal assessment message appeared below the flowchart in an italicised light blue/grey box, separated from the flowchart by a prominent green “Learn more…” tab/button.
Boehringer Ingelheim removed the material from the website the next working day and proposed reinstating it with the renal function statement moved above the diagram.

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No breach of Clause 7.2 in relation to not having a separate flowchart box prompting bleeding-risk consideration in patients aged 80+ (the reduced dose recommendation for ≥80s was consistent with the SPC).
Breach of Clause 7.2: the flowchart/page was misleading because it did not clearly bring the CrCl <30 mL/min contraindication to prescribers’ attention.
Breach of Clause 9.1: high standards were not maintained.
Breach of Clause 2: the presentation created patient safety concern and brought discredit upon the industry (contraindication looked like a footnote on a “simple dosing” page).
No appeal.

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