AstraZeneca voluntary admission: Nexium 40mg promoted too broadly for “unresolved GORD” (AUTH/2218/3/09)

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Key facts

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Case number	AUTH/2218/3/09
Company	AstraZeneca
Product	Nexium 40mg (esomeprazole)
Issue	Promotion/distribution implied Nexium 40mg use for “unresolved GORD” generally, without sufficient clarity that 40mg required diagnosis of erosive reflux oesophagitis per SPC Section 4.2
Materials	One detail aid (“Unresolved GORD corrodes peoples lives”) and two independently produced local treatment guidelines/pathways distributed by AstraZeneca
Applicable Code year	2008
Complaint received	18 March 2009
Case completed	24 April 2009
Appeal	No appeal
Breach clauses	3.2 (x2)
Sanctions	Undertaking received; Additional sanctions: Not stated
Company action noted	All relevant Nexium promotional material ceased on 25 February 2009; new materials to reflect full licence wording

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

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AstraZeneca voluntarily reported that promotion of Nexium 40mg (esomeprazole) was inconsistent with Section 4.2 (posology) of the Nexium SPC.
The issue arose during an internal review of the Nexium campaign; AstraZeneca concluded some materials did not reflect the full wording of SPC Section 4.2 for the 40mg dose.
The SPC distinguished doses within GORD: 40mg for treatment of erosive reflux oesophagitis; 20mg for long-term management of healed oesophagitis; and 20mg for symptomatic GORD in patients without oesophagitis (with further investigation if symptoms not controlled after 4 weeks).
A detail aid (“Unresolved GORD corrodes peoples lives”) positioned Nexium 40mg as a solution for patients with “unresolved GORD” (a population that could include patients with or without oesophagitis).
Two independently produced local treatment pathways/guidelines distributed by AstraZeneca positioned Nexium 40mg as second-line treatment for unresolved reflux-type dyspepsia/GORD after a generic PPI, without making clear that a diagnosis of erosive reflux oesophagitis was needed before starting 40mg.
AstraZeneca stopped all relevant Nexium promotional material on 25 February 2009 while clinical discussions were carried out and stated new materials would take account of the full wording of the licence.
The PMCPA Director treated the voluntary admission as a complaint because promotion inconsistent with the SPC was potentially serious.

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Breach ruled: Clause 3.2 (in relation to the detail aid pages promoting 40mg for unresolved GORD).
Breach ruled: Clause 3.2 (in relation to each of the two independently produced guidelines distributed by AstraZeneca).
No appeal.

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