AUTH/3231/7/19 and AUTH/3255/7/19 - Complainant v Shield and Norgine

Feraccru website

  • Received
    26 July 2019
  • Case number
    AUTH/3231/7/19 and AUTH/3255/7/19
  • Applicable Code year
  • Completed
    28 January 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the Review

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about claims on the Feraccru (ferric maltol) website. Feraccru was used to treat adults with iron deficiency; it had been marketed by Shield Therapeutics PLC. Norgine Pharmaceuticals Limited became the marketing authorization holder in February 2019.

The complainant noted that the claim that Feraccru was well tolerated would reassure clinicians although the summary of product characteristics (SPC) did not give the same level of reassurance. The complainant stated that in total there were 6 adverse drug effects in the common category and so in his/her view, Feraccru was definitely not well tolerated without a caveat.

The complainant further noted that a web-page explaining how Feraccru worked stated that:

‘Feraccru creates a stable complex for delivery by tightly binding ferric iron (Fe3+) to three maltol molecules .Fe3+ in Feraccru remains tightly bound to maltol until the point of iron absorption [Barrand et al 1991 and Barrand and Callingham 1991], preventing damage by free radicals in the gastrointestinal mucosa that may cause inflammation [Erichsen et al 2003].

Like other oral treatments, Feraccru is physiologically absorbed to avoid iron overload.’

What was not evident was that two of the papers cited (Barrand et al and Barrand and Callingham) were on the rat model. Furthermore, a third paper (Erichsen et al) did not support how Feraccru prevented damage by free radicals; it merely showed how that happened in a different oral iron. The complainant queried whether there was evidence to support the text which he/she found very misleading.

Finally, the complainant alleged that the Feraccru website to the general public promoted Feraccru. The complainant provided a page headed ‘What is iron deficiency and iron deficiency anaemia?’. The page then described the conditions and suggested that if readers were concerned they should speak to a health professional. It appeared that there was a link to the Feraccru product information.

The detailed response from Shield and Norgine is given below.

The Panel noted the incidence of the most frequently reported adverse reactions given in the Feraccru SPC which were described as mainly mild to moderate in severity. The European public assessment report (EPAR) described the safety profile of ferric maltol in the pivotal trial as reassuring. It further stated that, in general, the product was well tolerated and the profile of adverse events was expected since adverse events were similar to those described for other iron containing compounds and their incidence was low. The EPAR conclusion on the clinical safety was described as ‘… an acceptable safety profile although 18% of patients discontinued treatment …’.

The Panel also noted the companies’ submission regarding the differences between tolerability and adverse events and that the pivotal studies involved patients with inflammatory bowel disease. Further the Panel did not consider that the complainant had shown on the balance of probabilities that there was evidence to show the medicine was not well tolerated. Taking all the circumstances into consideration the Panel did not consider that the number of common adverse events necessarily meant that the product was not well tolerated. The Panel did not consider that the complainant had established that the claim was inconsistent with the SPC as alleged. Thus the Panel ruled no breaches of the Code.

The Panel noted that the information about the mechanism of action was based on two studies in rats. This was not mentioned in the description of how Feraccru worked on the website as provided by the complainant. The SPC stated that the complex dissociated on uptake from the gastro-intestinal tract and the complex itself did not enter the systemic circulation. The SPC did not mention that the damage by free radicals which might cause inflammation was prevented. The Panel noted that the information on the website in this regard was referenced to Erichsen et al and Feraccru was not used in Erichsen et al. The Panel considered that the claim at issue implied that there was direct data to show that Feraccru, due to its mechanism of action, prevented damage by free radicals in the gastrointestinal mucosa that might cause inflammation and that was not so. The Panel considered that the use of a reference showing activities of free radicals was not necessarily a breach of the Code. The question to be considered was whether the information misled as to the significance of the data or was extrapolated to the clinical situation.

The Panel considered it was not clear that the data related to two studies on animals or that the third study did not involve Feraccru and in this regard the material was misleading and not capable of substantiation. The Panel therefore ruled breaches of the Code.

The Panel considered that a page for the general public referring to a disease which linked to a product, advertised that medicine to the public. Feraccru was a prescription only medicine and the Panel ruled a breach of the Code as acknowledged by the companies.