Otsuka Europe & Otsuka UK: voluntary admission over prescribing information discrepancies (Abilify, Abilify Maintena, Jinarc, Samsca)

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Key facts

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Case numbers	AUTH/3219/6/19 and AUTH/3220/6/19
Companies	Otsuka Pharmaceuticals Europe Ltd; Otsuka Pharmaceuticals UK Ltd
Type	Voluntary admission (treated as a complaint under Constitution and Procedure Paragraph 5.6)
Issue	Errors and omissions / discrepancies between SPCs and prescribing information; associated materials withdrawn
Medicines	Abilify (aripiprazole); Abilify Maintena (aripiprazole); Jinarc (tolvaptan); Samsca (tolvaptan)
Key breach driver	Samsca prescribing information not consistent with SPC (including “interrupted” vs “interrupted or discontinued”; frequency thresholds > vs ≥; and omission of acute hepatic failure in Otsuka Europe PI)
Materials withdrawn	98 job bags (33 Europe; 65 UK)
Time in use	Prescribing information available for use on material for between 2 and 8 months (depending on medicine); dates provided as variously between 5 November 2018 and 26 June 2019
Complaint received	25 June 2019
Case completed	03 July 2020
Applicable Code year	2019
No breach clause(s)	Clause(s) 4.1 (in relation to some medicines/elements)
Breach clause(s)	2; 4.1; 9.1; 29
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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Otsuka Pharmaceuticals Europe Ltd and Otsuka Pharmaceuticals UK Ltd made a joint voluntary admission that there were errors and omissions in current prescribing information (PI) for Abilify, Abilify Maintena, Jinarc and Samsca.
Otsuka Europe said its centralised PI drafting/revision process meant similar issues were likely across European affiliates, including the UK.
After an internal review earlier in 2019 concluded no immediate revisions were needed, an independent external consultant review began in early June 2019, focusing on alignment with current SPCs.
On 20 June 2019, senior management discussed the independent review results and identified discrepancies between SPCs and PI (eg missing potentially serious events, omitted warnings, and use of “unknown” without clarity that it referred to frequency).
Otsuka Europe initiated a European-wide recall/withdrawal of impacted PI and associated materials; PI had been available for use on materials for between two and eight months depending on the medicine.
In total, 98 job bags were withdrawn (33 in Europe and 65 in the UK).
PMCPA also received correspondence from a group of concerned employees (not treated as a complaint), raising concerns about governance, signatory trust, and internal handling of PI issues; anonymised extracts were shared with Otsuka for response.

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No breach was ruled for Clause 4.1 in relation to Jinarc PI (based on the omissions identified by the independent review, and on the assumption the PI provided matched that on the materials at issue).
No breach was ruled for Clause 4.1 in relation to Abilify/Abilify Maintena PI (same assumption regarding PI on materials).
For Samsca:
- No breach of Clause 4.1 for Otsuka UK PI dated December 2018 regarding omission of acute hepatic failure (it was included).
- Breach of Clause 4.1 for Otsuka Europe PI dated October 2018 because acute hepatic failure (frequency not known) was omitted.
- Breach of Clause 4.1 for both Otsuka Europe and Otsuka UK because Samsca PI was not consistent with the SPC on: (1) instruction to “interrupted” vs “interrupted or discontinued” when serum sodium increases, and (2) frequency definitions using > instead of ≥ for “very common” and “common”.
Breach of Clause 9.1 (failed to maintain high standards) for both companies.
Breach of Clause 2 (bringing discredit/reducing confidence) for both companies, including due to failure to comply with undertakings.
Breach of Clause 29 for failure to comply with undertakings:
- Otsuka UK: one breach of Clause 29.
- Otsuka Europe: two breaches of Clause 29.

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