AUTH/3271/10/19 - Complainant v Napp


  • Received
    28 October 2019
  • Case number
  • Applicable Code year
  • Completed
    25 September 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about Napp Pharmaceutical’s Invokana (canagliflozin) website. Invokana was indicated for use alone or in combination therapy in patients with type 2 diabetes.

The complainant noted that the landing page of the website had two sections identified – one to take UK health professionals to the Invokana health professional website and another to take patients or members of the public to patient information pages. The complainant alleged that the section for patients and members of the public listed facets of Invokana and therefore promoted the medicine to members of the public.

The complainant stated that of more concern, was that the prescribing information on the health professionals’ part of the website did not refer to necrotising fasciitis of the perineum (Fournier’s gangrene). This was a very serious addition to the summary of product characteristics (SPC) that Napp appeared not to have updated. The complainant alleged that Fournier’s gangrene was also not listed in the safety section of the Invokana website. The complainant submitted that this was an issue of patient safety; mention of Fournier’s gangrene should be on all other materials and communicated to representatives. The complainant noted that the missing text on gangrene was very different to gangrene of the extremities.

The detailed response from Napp is given below.

The Panel noted that the opening page of the section of the website that was displayed after the reader selected that they were a patient or a member of the general public stated ‘Welcome to this website which aims to provide you with more information about your condition and the medicine your doctor or nurse has prescribed. It is also very important that you read the Patient Information Leaflet for lnvokana’. The Panel noted that this section of the website included five sections including information on how Invokana worked and how it should be taken The Panel noted that whilst the section providing promotional information to health professionals was clearly labelled and was separated from the section containing information for patients/members of the public, it was clear that the latter was aimed specifically at patients who had been prescribed Invokana and there was thus no information for the general public as required by the Code and a breach was ruled.

With regard to the information for patients and the public, the Panel noted that under the heading of ‘What else do you need to know about Invokana?’, it was stated that although the medicine was not for weight management nor for the management of high blood pressure, Invokana might result in some weight loss when first taken (2 – 4kg) and that it could also lower blood pressure. The Panel considered that such claims for the product effectively promoted Invokana to the public and a breach of the Code was ruled. The Panel noted that the prescribing information dated January 2019, which was available on the website when the complaint was submitted, included necrotising fasciitis of the perineum (Fournier’s gangrene) in the special warnings and precautions section. The Panel therefore ruled no breach of the Code.

The Panel noted Napp’s submission that, although an oversight meant that updated information on Fournier’s gangrene was not included within the Safety and Tolerability section of the health professional section of the website, the updated prescribing information and a link to the Invokana SPC on the eMC website containing such information was provided. The Panel noted that Fournier’s gangrene was a rare but serious and potentially life-threatening infection that required urgent medical attention. The Panel further noted that marketing authorisation holders of products containing SGLT2 inhibitors were specifically required to notify health professionals with regards to this condition. In the Panel’s view, it should therefore have been included in the safety and tolerability section rather than relying on its inclusion in other documents (the SPC and the prescribing information) to which the reader was referred. Failure to specifically refer to Fournier’s gangrene within the Safety and Tolerability section of the website was misleading and meant that the information given did not reflect available evidence. Breaches of the Code were ruled including that high standards had not been maintained. As no information had been given, there could be no breach of Clause 7.4 which required any information, claim or comparison to be capable of substantiation. No breach of the Code was ruled.

The Panel noted that a ruling of a breach of Clause 2 was a sign of particular censure and reserved for such. The Panel noted its rulings and comments above but decided, on balance, that the circumstances of this case did not merit a ruling of a breach of Clause 2. No breach was ruled.