Syner-Med detail aid ruled misleading on Ferinject dosing particulars (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 misleadingly simplified/omitted key dosing qualifiers (weight-based limit, weekly frequency, cumulative dose calculation)
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 same as 2008 Code; case considered under 2008 Constitution and Procedure
Breaches/clauses	Breach: Clause 7.2. No breach: 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 detail aid titled “The next generation of intravenous iron” (ref F07/01-05-08-039).
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 discovered dosing qualifiers: maximum dose 1,000mg iron per week and should not exceed 15mg/kg body weight (stated in smaller print on page 9 of the detail aid).
The complainant alleged the detail aid was misleading because patients might need more than one dose.
The complainant also stated she had discovered the FDA had refused to approve Ferinject in the US because of safety issues and that 10 deaths occurred during trials.

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Safety claim: The Panel found insufficient evidence (on the balance of probabilities) that Syner-Med representatives described Ferinject as “safe”; no breach was ruled for Clauses 7.9 and 7.10.
Dosing presentation: The Panel ruled the detail aid was misleading regarding dosage particulars because key qualifying information was omitted or separated across pages; breach of Clause 7.2 was ruled.
The Panel noted the SPC dosing was not straightforward and required individual calculation of cumulative dose, which must not be exceeded.

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Clause 7.2 (2008 Code): Breach (misleading presentation of dosage particulars in the detail aid).
Clause 7.9 (2008 Code): No breach (insufficient evidence that representatives described the product as “safe”).
Clause 7.10 (2008 Code): No breach (insufficient evidence; Panel did not find the alleged “safe” description proven).

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