Shield: Feraccru HCP website FAQ on pregnancy/breastfeeding omitted key SPC precaution (breach Clauses 3.2, 7.2, 9.1)

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Key facts

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Case	AUTH/3134/12/18
Parties	Anonymous complainant v Shield
Product	Feraccru (ferric maltol)
Channel	Website FAQs for health professionals
Main issue(s)	FAQ wording on (1) Hb/IBD/CKD and (2) pregnancy/breastfeeding vs SPC
Applicable Code year	2016
Complaint received	17 December 2018
Case completed	2 April 2019
Appeal	Appeal by respondent; unsuccessful
No breach	Clause 2 (and no breach found for the Hb/CKD FAQ issue)
Breach	Clauses 3.2, 7.2, 9.1 (pregnancy/breastfeeding FAQ)
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous complainant (described as a concerned UK health professional) challenged content in the FAQs on Shield’s Feraccru (ferric maltol) website for health professionals.
FAQ 1 (Hb): The site stated Feraccru should not be used in IBD patients with Hb <9.5 g/dL, and added: “However, our phase 3 CKD study included patients with haemoglobin levels as low as 8 g/dL.”
FAQ 2 (pregnancy/breastfeeding): The site stated: “We do not have any clinical data in this population. A benefit/risk assessment should be made before prescribing Feraccru.”
The complainant said the pregnancy/breastfeeding FAQ was weaker than the SPC, which stated: “As a precautionary measure, it is preferable to avoid the use of Feraccru during pregnancy” and similarly during breast-feeding.
On appeal, it was noted the FAQ response used superscript references (1,4) linked to a separate references page; the FAQ page itself did not explain what the superscripts referred to, and the SPC/PIL were unnumbered links at the bottom of the page.

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No breach was found for the Hb/CKD FAQ wording (the Panel said it could have been better worded but was not misleading and did not advocate use beyond the SPC given the broad indication).
Breach was found for the pregnancy/breastfeeding FAQ because it omitted very relevant SPC information (the precautionary measure to avoid use), making the answer misleading and inconsistent with the SPC.
The Appeal Board upheld the Panel’s rulings for the pregnancy/breastfeeding FAQ and the appeal was unsuccessful.
No breach of Clause 2 was ruled (Panel said the circumstances did not warrant Clause 2, reserved for particular censure).

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