AUTH/3618/3/22 - Complainant v AstraZeneca

Promotion of Forxiga

  • Received
    11 March 2022
  • Case number
  • Applicable Code year
  • Completed
    03 April 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to dosage claims about Forxiga (dapagliflozin) made by a representative and on a promotional website.

The Panel ruled a breach of the following Clause(s) of the 2021 Code in relation to the claims ‘Start FORXIGA 10mg today’ and ‘FORXIGA 10mg. Simple once-daily dosing – start on 10mg, stay on 10mg, no need for uptitration’, which had important qualifying safety information about a lower 5mg starting dose for patients with severe hepatic impairment in a small footnote that could have easily been missed:

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

Providing misleading information

Breach of Clause 6.2

Providing misleading information which was not capable of substantiation

Breach of Clause 11.2

Promotion inconsistent with the summary of product characteristics

Breach of Clause 14.4

Not encouraging the rational use of a medicine

The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to the allegation that a claim about cardiorenal benefits was incapable of substantiation and for a lack of evidence that a representative misleadingly implied that all patients could start on Forxiga 10mg without referring to the lower 5mg starting dose required for patients with severe hepatic impairment:

No Breach of Clause 6.2

Requirement that information, claims or comparisons must be capable of substantiation

No Breach of Clause 17.9

Requirement that representatives’ briefing material must comply with the relevant requirements of the Code

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