Eisai breached ABPI Code over Zonegran detail aid implying weight-loss benefit (AUTH/2500/4/12)

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Key facts

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Case number	AUTH/2500/4/12
Parties	Anonymous v Eisai
Product	Zonegran (zonisamide)
Issue	Detail aid presentation implied weight-loss benefit/selection in overweight epileptic patients; insufficient clarity that weight loss was a side effect and insufficient context on evidence limitations
Applicable Code year	2011
Complaint received	20 April 2012
Case completed	20 June 2012
Appeal	No appeal
Materials assessed	Zonegran detail aid (ref Zonegran-UK2375a); Wellmer et al briefing document referenced (ref Zonegran-UK2373)
Breach clauses	7.2, 7.10, 9.1
No breach clauses	2
Sanctions	Undertaking received

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

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An anonymous consultant neurologist complained that an Eisai representative’s discussion and promotional materials for Zonegran (zonisamide) implied it could be used in overweight epileptic patients.
Zonegran was indicated for adults with partial seizures; weight loss was a potential side effect per the SPC, not an indication.
The complainant was anonymous and could not be contacted; Eisai could not identify the representative, so the Panel assessed the allegation against the Zonegran detail aid (ref Zonegran-UK2375a).
The detail aid included a final section “Will weight gain be an issue?” featuring Wellmer et al (2009) and a bold claim: “BMI decrease was significant in patients who were overweight prior to Zonegran initiation”.
Weight loss/anorexia were not clearly handled as adverse effects within the “What about side effects?” section; weight-related content was separated and positioned at the end of the detail aid.
The detail aid did not state study limitations or that Wellmer et al was retrospective; there appeared to be no briefing material for the detail aid.

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Breach of Clause 7.2 (misleading) in relation to the detail aid’s presentation of Zonegran’s effect on weight.
Breach of Clause 7.10 (exaggeration) because the material was not clear about weight loss being a side effect and risked implying a benefit/indication.
Breach of Clause 9.1 (high standards) due to the way the information was presented and lack of adequate supporting/briefing material.
No breach of Clause 2 (the Panel did not consider the matter warranted the level of censure under Clause 2).
No appeal.

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