Bristol-Myers Squibb & Pfizer: Eliquis HCP website omitted SSRI/SNRI bleeding-risk caution (AUTH/3155/2/19, AUTH/3156/2/19)

📊

Key facts

⌄

Case numbers	AUTH/3155/2/19 and AUTH/3156/2/19
Parties	Complainant v Bristol-Myers Squibb and Pfizer
Product	Eliquis (apixaban)
Material	Eliquis website (health professional site), special warnings and precautions for use section
Main issue	Omission of SSRI/SNRI cautions while listing NSAID/aspirin caution on a page about interactions affecting haemostasis
Applicable Code	2016
Complaint received	5 February 2019
Case completed	2 May 2019
Appeal	No appeal
Breach clauses	7.2, 9.1
No breach clauses	2, 3.2
Sanctions	Undertaking received

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A UK health professional complained about the Eliquis (apixaban) health professional website section on special warnings and precautions for use.
The page advised care when Eliquis was used with NSAIDs (including aspirin) but did not mention that the updated SmPC also required care with SSRIs and SNRIs (as well as NSAIDs/aspirin).
The companies said the page went live in May 2018 and the SmPC was updated later (CHMP opinion 18 June 2018; European Commission decision 3 August 2018).
They updated links on the page to the amended SmPC/prescribing information, but the page text itself was not updated to add SSRI/SNRI cautions (they said, in hindsight, it would have benefitted from revision and was being updated).
The Panel considered the page implied it contained all relevant interactions affecting haemostasis, but it did not.

⚖️

⌄

Breach of Clause 7.2 (misleading information due to omission).
No breach of Clause 3.2 (the omission did not necessarily make the material inconsistent with the SmPC).
Breach of Clause 9.1 (failure to maintain high standards).
No breach of Clause 2 (not considered sufficiently serious to warrant particular censure in the circumstances).
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access