AUTH/2173/10/08: Nurse v Syner-Med — Ferinject detail aid and misleading administration messaging | PMCPA Case

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Key facts

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Case number	AUTH/2173/10/08
Complainant	Nurse
Company	Syner-Med (Pharmaceutical Products) Limited
Product/material	Ferinject detail aid: “The next generation of intravenous iron” (ref F17)
Issue	Allegedly inaccurate/misleading administration information for CosmoFer and “Single dose delivery” messaging for Ferinject
Applicable Code year	2008
Complaint received	10 October 2008
Case completed	25 November 2008
Appeal	No appeal
Breach clauses	Clause 7.2 (x2)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A nurse complained about a revised Ferinject (ferric carboxymaltose) detail aid titled “The next generation of intravenous iron” (ref F17) issued by Syner-Med.
Page 1 listed features of the “next generation intravenous iron”, including “Single dose delivery”, and included a chart comparing administration details for products including CosmoFer (iron(III) hydroxide dextran complex).
The complainant alleged the chart implied CosmoFer could be given as a 200mg bolus (and suggested a short administration time), and challenged the statement that a 1000mg infusion would take 4–6 hours.
The complainant also alleged “Single dose delivery” was misleading for Ferinject because 1000mg depended on patient weight (eg needing to weigh over 67kg to receive 1000mg).
Syner-Med argued the statements were consistent with the CosmoFer SPC and that the chart separated test-dose time from the remaining dose time; it also argued page 1 did not refer to prescribing Ferinject.

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Breach upheld: The CosmoFer administration chart was not sufficiently clear and was misleading (Clause 7.2).
No breach: The statement that a 1000mg CosmoFer infusion time was 4–6 hours was not misleading (no breach of Clause 7.2 on that point).
Breach upheld: The page 1 claim/feature “Single dose delivery” was misleading in context (Clause 7.2).
No appeal.

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