Bristol Myers Squibb & Pfizer: Eliquis patient booklets on website found misleading after SPC updates (AUTH/3595/1/22, AUTH/3596/1/22)

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Key facts

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Case numbers	AUTH/3595/1/22 and AUTH/3596/1/22
Parties	Complainant v Bristol Myers-Squibb and Pfizer
Product	Eliquis (apixaban)
Channel/material	Four patient information booklets on the Eliquis website (patient materials section)
Main issue	Booklets not updated after SPC updates; omissions/inaccuracies found misleading (not sufficient to rely on PIL)
Key misleading points identified by Panel	Omission of antiphospholipid syndrome warning; inaccurate absolute statement about not taking Eliquis if taking medicines to prevent blood clotting (despite specific exceptions such as UFH during catheter ablation)
Applicable Code	2021
Complaint received	04 January 2022
Case completed	09 March 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 5.1
No breach clauses	Clause 2; Clause 6.1
Sanction	Undertaking received

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

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A GP complainant challenged four patient information booklets hosted in the “patient materials” section of the Eliquis (apixaban) website, alleging they were not updated to reflect multiple SPC updates since April 2019.
The materials included booklets for: stroke prevention in NVAF; switching from warfarin to Eliquis; treatment/prevention of recurrent DVT/PE; and VTE prevention after hip/knee replacement surgery.
BMS responded on behalf of the BMS/Pfizer Alliance (BMS certified the booklets). Booklets 1–3 were prepared April 2019, certified June 2019 and recertified without changes on 10 June 2021; Booklet 4 on the website was dated July 2021 (the Alliance said an April 2019 version did not exist).
The Alliance argued the booklets were supplementary to the patient information leaflet (PIL), repeatedly signposted to the PIL, and were reviewed against SPC/PIL updates with a decision that no booklet updates were required.
The Panel assessed specific SPC/PIL changes since April 2019 and whether omissions made the booklets misleading/inaccurate for their intended patient audience.

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Breach of Clause 6.1 (Including misleading and inaccurate information) in relation to each of the four booklets.
Breach of Clause 5.1 (Failing to maintain high standards) in relation to each of the four booklets.
No breach of Clause 6.1 (Requirement that information must be accurate, up-to-date and not misleading) in relation to other alleged omissions (eg hair loss, erythema multiforme, fluconazole, cardioversion imaging, pregnancy wording, reversal agent, sodium statement).
No breach of Clause 2 (Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry). The Panel did not consider patient safety prejudice had been established and treated Clause 2 as reserved for particular censure.
No appeal.

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Breach of Clause 6.1 Including misleading and inaccurate information
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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