Pfizer websites: out-of-date prescribing information on Vfend leavepiece and Depo‑Provera PI (AUTH/2925/1/17)

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Key facts

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Case	AUTH/2925/1/17
Complainant	A health professional (previously worked in the pharmaceutical industry)
Company	Pfizer Limited
Channel	Websites
Complaint received	03 January 2017
Case completed	03 April 2017
Applicable Code year	2016
Products/materials	Vfend leavepiece (VFE1771); Tygacil leavepiece (TYG162); Ecalta leavepiece (ECA359); Depo‑Provera PI document (DP 13_0); Sayana Press PI document (PP-SAY-GBR-0071); Champix webpage linking to EAGLES e-reprint
Breach findings	Clause 4.1 (Vfend; Depo‑Provera); Clause 9.1
No breach findings	Clause 4.1 (Tygacil; Ecalta; Sayana Press; Champix e-reprint page)
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal
Published	May 2017 Code of Practice Review

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

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A health professional complained about Pfizer websites, alleging out-of-date prescribing information (PI) across multiple items.
Items cited: Vfend (voriconazole) leavepiece (ref VFE1771), Tygacil (tigecycline) leavepiece (ref TYG162), Ecalta (anidulafungin IV) leavepiece (ref ECA359), and website documents headed “Prescribing Information” for Depo‑Provera (ref DP 13_0) and Sayana Press (ref PP-SAY-GBR-0071).
The complainant compared PI dates/contents against the electronic medicines compendium (eMC), focusing on SPC Section 4.4 (special warnings and precautions) as clinically impactful.
Separately, the complainant queried a Champix (varenicline) webpage linking to an Elsevier-hosted e-reprint (EAGLES study), questioning whether it was independent or promotional and whether PI was appropriately available.

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Vfend leavepiece: Breach of Clause 4.1 (out-of-date PI remained on the website despite an updated version being certified).
Depo‑Provera PI on website: Breach of Clause 4.1 (PI not up-to-date and not aligned with updated SPC at time of complaint).
Tygacil leavepiece: No breach of Clause 4.1 (PI remained current; SPC revisions did not necessitate PI changes).
Ecalta leavepiece: No breach of Clause 4.1 (SPC change did not affect PI).
Sayana Press PI on website: No breach of Clause 4.1 (PI last updated May 2016 and remained current; later SPC revision did not require PI change).
High standards: Breach of Clause 9.1 (failures on Vfend and Depo‑Provera meant high standards were not maintained).
Champix e-reprint link: No breach of Clause 4.1 (PI accessible via a separate but prominent link near the publication link).

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Clause 4.1 – Breach (Vfend leavepiece; Depo‑Provera website PI). No breach (Tygacil; Ecalta; Sayana Press; Champix e-reprint page).
Clause 9.1 – Breach.
Clause 4.2 – Not ruled as a breach in the Panel rulings provided (although referenced in the complaint and discussed as defining PI content).

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