Bayer breach over Avelox leavepiece claim implying “first choice” for chest infections (AUTH/1940/1/07)

📅 2007 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/1940/1/07
PartiesGeneral Practitioner v Bayer
ProductAvelox (moxifloxacin)
MaterialLeavepiece (ref 6AVEL53)
Claim at issue“In chest infections, when your first reaction is concern, your first choice should be Avelox”
Main issueMisleading implication of “first choice” and potential inclusion of severe community acquired pneumonia (not licensed)
Applicable Code year2006
Breach clausesClause 7.2
Complaint received03 January 2007 (PDF text also states 04 January 2007)
Case completed01 February 2007 (PDF text also states 02 February 2007)
AppealNo appeal
SanctionsUndertaking received; additional sanctions not stated

Download the full case report (PDF)


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

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What happened

  • A general practitioner complained about the front cover headline on an Avelox (moxifloxacin) leavepiece (ref 6AVEL53) used by Bayer representatives in primary care.
  • The headline stated: “In chest infections, when your first reaction is concern, your first choice should be Avelox”.
  • The complainant said the message was misleading and suggested inappropriate first-line use for a newer antibiotic.
  • Bayer argued the claim was consistent with the marketing authorisation and that the licence did not specify treatment-line positioning.
  • The Panel considered that “chest infections which caused concern” could include severe community acquired pneumonia, for which Avelox was not licensed.
  • The Panel also found the wording “your first choice” implied Avelox was the (only) first choice, which was misleading.
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Outcome

  • Breach found: Yes.
  • Clause breached: Clause 7.2.
  • Key finding: The “first choice” headline was misleading because it implied primacy/exclusivity and could be read as advocating use in severe CAP (outside the licence).
  • Appeal: No appeal.
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