Takeda: Rienso promotion—website claims found misleading (but ‘high dose’ in ad upheld) (AUTH/2623/7/13)

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Key facts

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Case number	AUTH/2623/7/13
Parties	Anonymous complainant v Takeda UK Ltd
Product	Rienso (ferumoxytol)
Materials	Journal advertisement (Journal of Renal Nursing, 4 July 2013; ref April 2013 UK/RIE/1304/0040) and website www.anaemiazone.co.uk (ref FE120916)
Key issues	Use of “high dose”; “new” claim; outdated competitor (Monofer) dosing/injection comparison; contraindication statement applied to “all IV irons”; “cost effectiveness” heading for acquisition cost table; high standards
Complaint received	30 July 2013
Case completed	11 October 2013
Applicable Code year	2012
Appeal	No appeal
No breach clauses	Clause 2, Clause 7.2, Clause 7.4
Breach clauses	Clause 7.2 (x2), Clause 7.3, Clause 7.4 (x2), Clause 7.9, Clause 7.11, Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, non-contactable complainant challenged a Takeda journal advertisement for Rienso (ferumoxytol) and the linked website (www.anaemiazone.co.uk).
Rienso indication: IV treatment of iron deficiency anaemia in adults with chronic kidney disease (CKD); dosing described as one or two IV doses of 510mg depending on pre-treatment status.
The ad described Rienso as “high dose” (within the phrase “Short course, High dose, Rapid bolus injection”).
The website described Rienso as a “new” IV iron and repeated “new” in a “Why Rienso?” section.
The website included comparative content about competitor Monofer (number of bolus injections to deliver 1g iron), a statement about contraindications “as with all IV irons”, and a section headed “cost effectiveness” that presented acquisition costs.
Takeda acknowledged it had missed an update to the Monofer SPC because it monitored the eMC monthly; the Monofer SPC update was uploaded on 17 July 2013 (13 days before the complaint).

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No breach for the journal advertisement’s use of “high dose” (not a hanging comparison; supported by literature defining high dose iron as >200mg/month).
Breach for describing Rienso as “new” on the website beyond the permitted 12-month period.
Breach for outdated competitor information (Monofer dosing/injection comparison) not being up-to-date and not capable of substantiation.
Breach for the statement implying all IV irons were contraindicated in hypersensitivity to other iron preparations (not supported by competitor SPCs).
Breach for using the heading “cost effectiveness” for a section that only presented acquisition costs (misleading heading).
Breach for failure to maintain high standards.
No breach for the claim about Rienso’s structure allowing rapid administration of high doses (510mg) and for the claim that Rienso was “convenient” (on balance, not misleading).
No breach of Clause 2 (Panel did not consider the material brought discredit on, or reduced confidence in, the industry).

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