Janssen-Cilag: Risperdal Consta detail aid implied “neuroprotective effects” (AUTH/2253/7/09)

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Key facts

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Case number	AUTH/2253/7/09
Company	Janssen-Cilag Ltd
Product	Risperdal Consta (prolonged release risperidone)
Therapy area	Schizophrenia
Indication (as stated)	Maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics
Complainant	Consultant psychiatrist and visiting professor of psychiatry
Issue	Presentation implied neuroprotective effects for Risperdal Consta/risperidone; alleged lack of evidence/substantiation
Material type	Electronic detail aid / PowerPoint presentation (16-slide relapse prevention sub-section provided)
Applicable Code year	2008
Breach clauses	7.2, 7.4, 15.2 and 15.9
Complaint received	29 July 2009
Case completed	08 September 2009
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A consultant psychiatrist complained about promotion of Risperdal Consta (prolonged release risperidone) by Janssen-Cilag.
The representative showed a PowerPoint/electronic detail aid section discussing relapse prevention, grey matter deficits and “Latest thinking”, with a pop-up referencing a review (Lieberman et al, 2008) suggesting some atypicals may have greater “neuroprotective effects”.
Slides included product branding and the claim: “Risperdal Consta can help prevent relapse and help patients achieve remission”, alongside content about progressive brain tissue loss and neuroprotection.
The complainant argued there was insufficient data to support implying risperidone had neuroprotective effects; the paper provided did not justify such a campaign.
Janssen-Cilag said it did not intend to claim neuroprotection for Risperdal Consta and believed no such claim was made; it stated reps were trained verbally and given a guidance document.
The Panel reviewed the 16-slide relapse-prevention sub-section provided (not the entire presentation) and the representative briefing/guidance.

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The Panel ruled that, although there was no explicit claim, the slides clearly linked Risperdal Consta with neuroprotection and created the overwhelming impression that Risperdal Consta had neuroprotective effects.
The material was found misleading and incapable of substantiation regarding neuroprotection.
The representative, when presenting the material, was found to have failed to comply with relevant Code requirements.
The briefing material was found to advocate a course of action likely to lead to a breach (given the link between product and neuroprotection).
The Panel also highlighted the need for balance when presenting emerging clinical/scientific opinion, noting that “might” claims can still leave an impression that something “does” occur.

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