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PMCPA Case

Novo Nordisk breached ABPI Code over Saxenda leavepiece: missing ‘stopping rule’, PI inconsistency and 0845 AE reporting number (AUTH/3737/2/23)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3737/2/23
ComplainantHealth professional
CompanyNovo Nordisk
MedicineSaxenda (liraglutide)
MaterialPromotional leavepiece / “HCP discussion guide” (UK20SX00030)
Main issueOmission of stopping rule from indication on front page and from main body; PI indication not consistent with SPC; AE reporting used an 0845 number; lack of guidance when providing materials to a pharmacy group with online marketing
Stopping rule text (as cited)“Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight”
Complaint received13 February 2023
Case completed27 November 2023
Applicable Code2021
Breach clauses5.1, 11.2, 12.1
No breach clauses2, 26.1
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

Download the full case report (PDF)

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

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What happened

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  • A health professional complained about a Saxenda (liraglutide) promotional leavepiece (UK20SX00030), described as an “HCP discussion guide”.
  • The complainant alleged the leavepiece was freely available online to the public (found via Google) despite being intended for health professionals.
  • The complainant alleged the indication on page 1 omitted part of the licensed indication (the 12-week “stopping rule”): “Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight”.
  • The complainant alleged the prescribing information (PI) also omitted the stopping rule from the indication and placed it under “Posology and administration”, making it less noticeable.
  • The complainant alleged the adverse event reporting telephone number was an 0845 number, potentially discouraging reporting due to cost.
  • Novo Nordisk said the stopping rule was included in the PI (under Posology and Administration), the leavepiece was certified 19 March 2020 and withdrawn 15 December 2021, and it had no evidence it directed the pharmacy group to publish the leavepiece online.
  • The Panel considered the leavepiece’s emphasis on long-term use (1-year and 3-year data) and concluded the stopping rule was an important part of the licensed indication and benefit/risk profile and should have been made clear.
  • The Panel also considered Novo Nordisk’s interactions with a pharmacy group: materials were likely provided without clear guidance, despite the pharmacy group’s online marketing activity and a website with “Saxenda” in the URL.
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Outcome

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  • Breach found for omission of the stopping rule from the front-page indication and from the main body, making the material inconsistent with the SPC.
  • Breach found because the PI indication was not consistent with the SPC (stopping rule omitted from the PI indication).
  • Breach found for failure to maintain high standards (linked to the omission/placement of the stopping rule, the 0845 AE reporting number, and lack of clear guidance when providing materials to the pharmacy group).
  • No breach found for advertising a POM to the public (insufficient evidence Novo Nordisk was responsible for the pharmacy group publishing the leavepiece online).
  • No breach found of Clause 2 (Panel considered the other rulings adequately addressed the concerns).
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