Napp: Invokana website ruled to promote to the public and omit key safety warning in HP safety section (AUTH/3271/10/19)

📊

Key facts

⌄

Case	AUTH/3271/10/19
Company	Napp Pharmaceuticals Ltd
Product	Invokana (canagliflozin)
Material	Website
Complainant	Concerned UK health professional
Main issues	Promotion of a POM to the public via patient/public pages; lack of general-public information; omission of Fournier’s gangrene from HP “Safety and Tolerability” section
Breach clauses	7.2, 7.9, 9.1, 26.1, 28.1
No breach clauses	2, 4.1, 7.4
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	28 October 2019
Case completed	25 September 2020
Appeal	No appeal
Applicable Code year	2019

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A UK health professional complained about Napp’s Invokana (canagliflozin) website, which had a landing page splitting users into a health professional area and a patient/general public area.
The complainant alleged the patient/general public section promoted Invokana to the public by listing product facets.
The complainant also alleged the health professional area prescribing information did not include necrotising fasciitis of the perineum (Fournier’s gangrene), and that it was not listed in the website’s safety section.
Napp stated the prescribing information available on the site (dated January 2019) did include Fournier’s gangrene, and the site linked to the up-to-date SPC on eMC.
Napp accepted an oversight: Fournier’s gangrene was not included in the “Safety and Tolerability” section of the health professional website.

⚖️

⌄

Breach: Clause 28.1 (no information for the general public as required; the “public” section was aimed at patients prescribed Invokana).
Breach: Clause 26.1 (claims such as potential weight loss and lowering blood pressure effectively promoted a POM to the public).
No breach: Clause 4.1 (prescribing information on the website included Fournier’s gangrene in special warnings and precautions).
Breach: Clause 7.2 and Clause 7.9 (failure to refer to Fournier’s gangrene in the health professional “Safety and Tolerability” section was misleading and did not reflect available evidence).
No breach: Clause 7.4 (as no information had been given in that section, there could be no substantiation breach).
Breach: Clause 9.1 (high standards not maintained).
No breach: Clause 2 (Panel decided the circumstances did not merit particular censure).
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access