AUTH/2173/10/08: Nurse v Syner-Med – Ferinject detail aid and misleading administration information | 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)
Complaint received	10 October 2008
Case completed	25 November 2008
Applicable Code year	2008
Appeal	No appeal
Breach clauses	Clause 7.2 (x2)
Key issues	Misleading administration chart for CosmoFer; misleading “Single dose delivery” impression for Ferinject on page 1
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 dextran).
The complainant alleged the chart implied CosmoFer could be given as a 200mg bolus (and too quickly), and challenged the stated 1000mg infusion time (4–6 hours).
The complainant also alleged “Single dose delivery” was misleading for Ferinject because 1000mg could only be given to patients above a certain body weight (per the SPC limit of 15mg/kg/week).
Syner-Med argued the statements were consistent with the CosmoFer SPC and that the page 1 “Single dose delivery” statement was a general desirable characteristic rather than prescribing guidance for Ferinject.

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Breach found: The CosmoFer administration chart was not sufficiently clear and was misleading (Clause 7.2).
No breach: The statement that a 1000mg CosmoFer infusion time would be 4–6 hours was not misleading as alleged (no breach of Clause 7.2 on that point).
Breach found: The page 1 claim/feature “Single dose delivery” was misleading because it would be read as applying to Ferinject and implied administration was straightforward when it was not (Clause 7.2).

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