AUTH/2874/9/16: Health professional v Shield (Feraccru journal ad) – No breach | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2874/9/16
Complainant	Health professional
Company	Shield Therapeutics UK Limited
Product	Feraccru (ferric maltol)
Material	Journal advertisement (Gastrointestinal Nursing, September 2016), ref UK/FER/2016/004f
Main claim challenged	“A safety profile comparable to placebo”
Indication context in ad	Iron deficiency anaemia in adult patients with IBD; further restricted to those who failed oral ferrous products
Clauses considered	2, 7.2, 9.1
Outcome	No breach
Complaint received	21 September 2016
Case completed	10 November 2016
Appeal	No appeal
Code year	2016

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 health professional complained about a one-page Feraccru (ferric maltol) journal advertisement by Shield Therapeutics UK (Gastrointestinal Nursing, September 2016; ref UK/FER/2016/004f).
The ad stated Feraccru was “a new oral iron alternative” for iron deficiency anaemia in adult patients with inflammatory bowel disease (IBD) who had failed oral ferrous products, and claimed “a significant 2.25g/dl increase in Hb at Week 12 and a safety profile comparable to placebo.”
The complainant alleged the “comparable to placebo” safety claim was misleading and could risk patient safety because prescribing information said Feraccru was not suitable for certain groups (eg children, pregnancy, severe IBD/IBD flare).
The PMCPA asked the company to consider Clauses 2, 7.2 and 9.1 (Code year 2016).

⚖️

⌄

No breach of the Code was ruled.
The Panel found the ad clearly stated the licensed indication and intended patient population (adults with IBD) and further restricted to those who had failed oral ferrous products.
The Panel did not consider the “safety profile comparable to placebo” claim misleading on the narrow ground alleged (ie, that some patient groups were excluded/not recommended in prescribing information).

🔒

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