AstraZeneca: Symbicort COPD formulary guide prescribing information challenged as out of date (AUTH/3319/3/20)

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Key facts

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Case number	AUTH/3319/3/20
Company	AstraZeneca UK Ltd
Complainant	Concerned UK health professional
Product	Symbicort (budesonide/formoterol)
Channel/material	Promotional material hosted on Guidelines in Practice website; downloadable formulary decision guide
Main issue	Alleged out-of-date PI due to omission of an SPC section 4.4 warning added since the guide was created
Key SPC text cited	“Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma”
Panel view	Guide related to COPD; cited warning was asthma-specific; no evidence it needed to be in COPD PI; complainant did not substantiate patient safety concern
Clauses considered	2, 4.1, 4.2, 9.1
Outcome	No breach
Complaint received	10 March 2020
Case completed	1 July 2020
Applicable Code year	2019
Appeal	No appeal

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

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A UK health professional complained about promotional material for Symbicort (budesonide/formoterol) created by AstraZeneca UK Ltd and hosted on the Guidelines in Practice website.
The complaint focused on a downloadable “formulary decision guide” and alleged the prescribing information (PI) was out of date because the SPC had been updated since the guide was created.
The complainant highlighted text added to SPC section 4.4: “Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma”.
The complainant alleged omission of that statement could be a patient safety issue, particularly as the material was intended to guide formulary decisions and treatment algorithms.
AstraZeneca responded that the guide related to COPD use and that it maintained separate, up-to-date PI for asthma and for COPD; the cited warning was specific to asthma and therefore not relevant to COPD PI.

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No breach of the Code was found.
No breach of Clause 4.1 (prescribing information) because there was no evidence the asthma-specific warning needed to be included in COPD prescribing information.
No breach of Clause 9.1 (high standards) because the complainant did not establish AstraZeneca failed to maintain high standards.
No breach of Clause 2 (bringing discredit) followed from the above rulings.

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