Syner-Med detail aid ruled misleading on Ferinject dosing claims (AUTH/2143/7/08)

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Key facts

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Case number	AUTH/2143/7/08
Case reference	Promotion of Ferinject
Complainant	Nurse
Respondent/company	Syner-Med (Pharmaceutical Products) Limited
Product(s)	Ferinject (ferric carboxymaltose)
Material/channel	Exhibition stand conversation; detail aid (“The next generation of intravenous iron”, ref F07/01-05-08-039)
Key issue	Whether safety was misrepresented verbally; whether the detail aid’s dosing claims were misleading due to omitted/segregated qualifying information
Dates (received/completed if stated)	Complaint received 17 July 2008; Case completed 28 August 2008
Appeal	Not stated
Code year	2006 Code clauses referenced as the same as 2008 Code; considered under the 2008 Constitution and Procedure
Breaches/clauses	Breach of Clause 7.2; No breach of Clauses 7.9 and 7.10
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A nurse complained about information provided at a Syner-Med exhibition stand about Ferinject (ferric carboxymaltose), an injectable iron preparation, and about a related detail aid.
The complainant said she was told Ferinject was an IV iron and that 1,000mg could be given in a single dose over 15 minutes.
The complainant said she asked about worldwide safety concerns and was informed that Ferinject was safe.
The complainant later noted the maximum dose was 1,000mg iron per week and should not exceed 15mg/kg body weight, which appeared in smaller print on page 9 of the detail aid (“The next generation of intravenous iron”, ref F07/01-05-08-039).
The complainant alleged the detail aid was misleading because patients might need more than one dose.
The complainant also stated she had discovered that the FDA had refused to approve Ferinject in the US because of safety issues and that 10 deaths occurred during trials.
The Authority asked Syner-Med to respond in relation to Clauses 7.2, 7.9 and 7.10 of the 2006 Code (the same as the 2008 Code). The case was considered under the 2008 Constitution and Procedure.

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The Panel ruled there was insufficient evidence, on the balance of probabilities, that Syner-Med representatives had described Ferinject as “safe”; no breach was found of Clauses 7.9 and 7.10.
The Panel ruled the detail aid was misleading regarding dosage particulars because dosage statements were too simple and omitted important qualifying information; a breach of Clause 7.2 was ruled.

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