Astellas UK & Astellas Europe: incomplete prescribing information used for years (AUTH/2939/2/17, AUTH/2940/2/17)

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Key facts

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Case numbers	AUTH/2939/2/17 (Astellas UK) and AUTH/2940/2/17 (Astellas Europe)
Issue	Failure to provide accurate prescribing information; omissions of serious/common adverse reactions and warnings/precautions; inconsistent seriousness categorisation
How identified	Routine re-approval alert for Flomaxtra XL PI; signatory noticed missing serious adverse reaction from SPC
Medicines with incomplete PI (Astellas UK)	Flomaxtra, Vesomni, Vesicare, Advagraf, Prograf, Modigraf, Mycamine
Medicines with incomplete PI (Astellas Europe)	Vesomni, Vesicare, Mycamine (retrospective), Qutenza (retrospective)
Immediate corrective action	Withdrawal/recall of PI and promotional items with incomplete PI; interim use of SPC supplemented with legal classification and cost (UK)
Applicable Code year	2016
Breach clauses	2, 4.1, 9.1
No breach clauses	4.10, 26.3
Sanctions	Undertaking received; public reprimand; audit of company’s procedures; reports to ABPI Board; Astellas UK suspension from ABPI membership extended
Voluntary admission received	22 February 2017
Complaint received	21 February 2017
Case completed	22 May 2019
Review publication	May 2020 Review (see also August 2017 and November 2018 Reviews)

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

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Astellas UK and Astellas Europe made a joint voluntary admission that prescribing information (PI) used in UK promotion was incomplete for multiple medicines.
The issue was discovered during routine re-approval of Flomaxtra XL PI in late November 2016, when a signatory noticed a serious adverse reaction in the SPC (Stevens–Johnson syndrome) was missing from the PI.
Initial review suggested omissions of three serious adverse reactions for Flomaxtra XL (Stevens–Johnson syndrome, syncope and priapism), but a wider investigation found broader omissions across products.
Omissions included: inconsistent categorisation of seriousness, missing serious adverse reactions, missing common adverse reactions, and missing warnings/precautions.
Astellas UK’s revision process had been wrongly limited to checking only amended sections rather than re-checking the PI in full at each revision—so incomplete PI could persist for years.
Astellas Europe (EMEA HQ) had no formal written process for PI development/revision and was not routinely notified of PI updates; brand teams used inconsistent approaches.
Given potential patient safety impact, the companies copied the MHRA into the voluntary admission; PMCPA treated the admission as a complaint under the Code.

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Breaches ruled: Clauses 2, 4.1 and 9.1.
No breach ruled: Clauses 4.10 and 26.3 (black triangle not required in prescribing information).
The Panel was extremely concerned that incomplete PI had been used for a number of years on large numbers of materials and that systems did not detect errors sooner.
The Panel reported both companies to the Appeal Board to consider further sanctions due to seriousness and patient safety implications.
The Appeal Board described the lack of PI updating processes as “shocking” and the delay in completing cross-checks as “totally unacceptable”.

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