GSK voluntary admission: out-of-date prescribing information used in Avandamet ads (AUTH/1922/11/06)

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Key facts

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Case number	AUTH/1922/11/06
Company	GlaxoSmithKline UK Ltd
Product	Avandamet (rosiglitazone/metformin)
Issue	Use of out of date prescribing information in advertisements
What was missing/changed	Macular oedema not referenced as a serious but rare side effect in the outdated PI
Period affected	30 August 2006 to end of November 2006 (approximately three months)
Volume	84 advertisements
How identified	Brought to GSK’s attention by Takeda (competitor) in November 2006
Complaint type	Voluntary admission treated as a complaint (potentially serious matter)
Applicable Code year	2006
Breach clauses	4.1 and 9.1
Clause 2	Not breached
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	28 November 2006
Proceedings commenced	29 November 2006
Completed	15 January 2007 (case report notes case completed 16 January 2007)
Appeal	No appeal
Published	February 2007 Code of Practice Review

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

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GlaxoSmithKline (GSK) voluntarily informed the PMCPA that out of date prescribing information (PI) had been used in Avandamet (rosiglitazone/metformin) advertisements.
The outdated PI (dated April 2006) was used in advertisements from 30 August 2006 until the end of November 2006 (approximately three months).
The PI should have been updated following an August 2006 SPC update; the main change was inclusion of macular oedema as a rare but serious side effect.
The issue was brought to GSK’s attention by a competitor (Takeda) in November 2006.
GSK stated the error arose from an oversight by an individual who did not create the required “job bags” for new advertisements with updated PI, around a period of high staff turnover.
GSK said it had previously sent a ‘Dear Doctor’ letter (20 December 2005) alerting prescribers to case reports of macular oedema and that regulators were reviewing the concern.
The Director treated the voluntary admission as a complaint because using incorrect PI for a long period was considered potentially serious.

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Breach of Clause 4.1 was ruled.
Breach of Clause 9.1 was ruled.
No breach of Clause 2 was ruled (Panel said the circumstances did not warrant the particular censure of Clause 2).
No appeal.

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