Janssen-Cilag: Risperdal Consta ad implied use in under-18s via imagery and “Prescribe early” strapline

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Key facts

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Case number	AUTH/2059/10/07
Complainant	Primary care trust medicines management director
Company	Janssen-Cilag Ltd
Product	Risperdal Consta (risperidone, long-acting injection)
Material	Journal advertisement (ref RISP/C/06-0038)
Main issue	Ad imagery/strapline could imply prescribing to under-18s despite SPC stating not studied in children/adolescents <18
Key quoted text	“Prescribe early, because what she loses, she could lose forever”
Applicable Code year	2006
Breach clauses	3.2, 7.2 and 7.8
Complaint received	17 October 2007
Case completed	14 November 2007
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A primary care trust medicines management director complained about a Janssen-Cilag journal advertisement for Risperdal Consta (risperidone, long-acting injection) (ref RISP/C/06-0038).
The ad showed a lone female figure in a playground walking away from a trail of items (including a doll, photograph album, wedding veil, handbag, toothbrush and hairbrush).
The complainant said the image depicted a child clearly under 18 and gave the immediate impression Risperdal Consta could be prescribed for a young teenager; the doll reinforced this.
The complainant pointed out the prescribing information stated the product had not been studied in children and adolescents under 18 and asked that the ad be withdrawn.
Janssen-Cilag said the items were visual metaphors for the effects of schizophrenia/relapse and denied any intention to imply use in children; the model was 33 years old.
The Authority asked Janssen-Cilag to respond under Clauses 3.2, 7.2 and 7.8 (Code year 2006).

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The Panel ruled the advertisement was misleading and inconsistent with the Risperdal Consta SPC because it was not made sufficiently clear the figure was at least 18.
Breaches were ruled for Clauses 3.2, 7.2 and 7.8.
No appeal.

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