Bristol Myers Squibb and Pfizer: Eliquis prescribing information in promotional email (AUTH/3289/12/19 & AUTH/3290/12/19)

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Key facts

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Case numbers	AUTH/3289/12/19 and AUTH/3290/12/19
Company	Bristol Myers Squibb and Pfizer (BMS/Pfizer Alliance)
Product	Eliquis (apixaban)
Material	Prescribing information attached to a promotional email
Complainant	Concerned UK health professional
Issue	PI revised July 2019; SPC updated Oct 2019 (reversal agent availability; overdose management). PI did not reference antidote/overdose and placed “see SPC” signpost later in text.
Complaint received	17 December 2019
Case completed	21 and 25 August 2020
Applicable Code year	2019
Breach findings	Clause 9.1 (breach); Clauses 2 and 4.1 (no breach)
Sanctions	Undertaking received; additional sanctions: Not stated
Appeal	No appeal

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

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A UK health professional complained about prescribing information (PI) attached to a promotional email for Eliquis (apixaban) received in December 2019.
The PI was last revised in July 2019, while the Eliquis SPC had been updated in October 2019.
The October 2019 SPC update added information on the availability of an agent to reverse Eliquis’ anticoagulant activity (SPC Section 4.4) and added reversal-agent wording to overdose management (SPC Section 4.9).
The PI included a ‘Haemorrhage risk’ paragraph and, later (after several paragraphs), a statement: “For information on reversal and managing bleeding, see SPC for further details”.
The PI did not explicitly reference an antidote/reversal agent and did not reference overdose.
The Alliance stated it had robust processes for SPC updates and concluded no PI change was needed in October 2019 because the PI already directed readers to the SPC for reversal/bleeding management.

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