AUTH/3678/8/22 - Complainant v AstraZeneca

Concerns about a Symbicort advertisement in MIMS

  • Received
    01 August 2022
  • Case number
  • Applicable Code year
  • Completed
    04 July 2023
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to an advertisement for Symbicort (budesonide, formoterol fumarate dihydrate) in MIMS placed by AstraZeneca. 

The Panel ruled a breach of the following Clauses of the 2021 Code because: 

  • the advertisement did not include reference to where the prescribing information could be found on the page of the advertisement, it was not visible
  • the advertisement misleadingly implied that all strengths of Symbicort could be prescribed for MART [maintenance and reliever therapy] when Symbicort 400/12 should be used as maintenance therapy only and the points in small font at the very bottom of the page in question were wholly insufficient to qualify the misleading impression given and use of the higher Symbicort dose (400/12) for reliever therapy had the potential to impact patient safety 

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 6.1

Making a misleading claim

Breach of Clause 6.2

Making an unsubstantiated claim

Breach of Clause 11.2

Promotion inconsistent with the SPC

Breach of Clause 12.7

Failing to include on the pages of a printed journal advertisement where the prescribing information was not visible, reference to where it could be found

 This summary is not intended to be read in isolation.
             For full details, please see the full case report below.