AUTH/2448/10/11: Pharmacist complaint about Pradaxa ‘Stroke Prevention’ leavepieces and representative conduct (No breach on appeal)

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Key facts

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Case number	AUTH/2448/10/11
Complainant	Pharmacist
Company	Boehringer Ingelheim
Product	Pradaxa (dabigatran) 110mg bd and 150mg bd
Activity/material	Two “Stroke Prevention” leavepieces; Pradaxa detail aid (certified sales aid ref DBG 2764); nurse education meeting
Key allegations	Misleading title “Stroke Prevention”; misleading tolerability claim vs warfarin; misleading bleeding claims re GI bleeding; rep glossed over GI side effects/PPI comment; MI data not mentioned
Panel decision	Initially ruled breaches for some claims (Clauses 7.2, 7.9, 9.1 and 2), later appealed
Appeal outcome	No breach of the Code (appeal successful on all points)
Clauses considered/listed	Clauses 3.2, 7.2, 7.9, 15.2, 15.9, 9.1 and 2
Complaint received	26 October 2011 (also stated as 28 October 2011 in the report)
Case completed	23 February 2012
Applicable Code year	2011

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

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A pharmacist complained about two promotional leavepieces for Pradaxa (dabigatran) 110mg bd and 150mg bd and a representative’s use of a Pradaxa detail aid at a nurse education meeting.
The complaint alleged the leavepiece title “Stroke Prevention” was misleading because Pradaxa was licensed for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with specified risk factors (not “stroke prevention” in isolation).
The complaint challenged the claim “In RE-LY, Pradaxa was generally as well tolerated as warfarin”, citing higher discontinuation and dyspepsia rates in RE-LY.
The complaint also challenged bleeding claims, arguing GI bleeding (especially with 150mg bd) and GI side effects were downplayed.
At a lunchtime meeting (NHS premises; five practice nurses), the representative used a certified sales aid (detail aid ref DBG 2764) and provided the two leavepieces plus an educational pack (DBG 2653). The complainant alleged the rep glossed over GI side effects, suggested “PPI cover might be required”, and did not mention MI data.
Boehringer Ingelheim stated materials were certified and MHRA pre-vetted; the full licensed indication appeared prominently under “Stroke Prevention”; and MI data was included in the materials (though not discussed verbally).

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Final decision (Appeal Board): No breach of the Code.
The Appeal Board ruled that, in context (including the bullet-point data immediately below), the challenged claims were not misleading.
All Panel findings of breach (Clauses 7.2, 7.9, 9.1 and 2) were overturned on appeal.

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