AUTH/2535/10/12: Patient v Pfizer — Champix (varenicline) patient leaflets and seizure warnings (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2535/10/12
Complainant	Member of the public (patient)
Company	Pfizer
Product	Champix (varenicline)
Indication referenced	Smoking cessation
Complaint received	05 October 2012
Case completed	06 March 2013
Applicable Code year	2012
Allegation summary	Failure to warn about seizures/convulsions; UK patient leaflets alleged to be misleading/unbalanced regarding seizure risk during/after treatment
Materials in scope	Pfizer-produced patient/HCP leaflets based on SPC/PIL (eg patient leaflet prepared November 2007); SPC/PIL themselves noted as regulatory documents outside promotion definition
Clauses considered	Clause 2, Clause 7.9, Clause 9.1, Clause 22.2
Panel decision	No breach
Appeal	Appeal by complainant; unsuccessful
Final decision	No breach upheld by Appeal Board
Notable post-appeal regulatory development	EU PRAC (Nov 2012) recommended updating SPC/PIL to include seizure-related events; updated SPC dated 11 March 2013 listed seizures in Section 4.4 and as an uncommon adverse effect in Section 4.8; PIL updated (approved 03/2013)

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

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A member of the public complained that Pfizer failed to warn consumers about serious side effects of Champix (varenicline), specifically convulsions/seizures, and alleged UK patient information was inadequate.
The complainant said she took Champix in January 2008 (planned 12 weeks; stopped at week 10 after depression and suicidal thoughts) and later experienced two convulsions and was diagnosed with epilepsy.
She cited non-UK materials (eg an Australia/New Zealand leaflet dated February 2007 mentioning “seizures or fits”, plus references to Canada/US information and FDA actions) and argued UK leaflets should have included seizure warnings.
PMCPA considered that UK SPCs and PILs are regulatory documents (outside the Code’s definition of promotion), but Pfizer also produced additional UK leaflets for patients/HCPs based on the SPC/PIL, which were within scope and had to reflect the SPC.
Pfizer stated that at the relevant time (January 2008) the UK SPC/PIL did not list seizures/fits as undesirable effects; Section 4.4 stated there was no clinical experience in patients with epilepsy. Pfizer said there was no evidence of a causal relationship between varenicline and seizure at that time.
The complainant appealed the Panel’s no-breach rulings; the Appeal Board reviewed the same core issue: whether Pfizer’s UK patient leaflet(s) were inconsistent with the evidence available in January 2008 and/or unbalanced.

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No breach of the Code was ruled by the Panel and upheld by the Appeal Board.
The Panel ruled that not referring to seizures/fits in Pfizer-produced UK patient leaflets available in January 2008 did not fail to reflect available evidence and did not make the material incorrect or unbalanced.
The Appeal Board upheld no breach, noting the complainant had not provided evidence (on the balance of probabilities) that Pfizer’s UK information in January 2008 was inconsistent with evidence available at that time.
Post-appeal information (for information only) indicated that in 2012/2013 EU pharmacovigilance review recommended updating the SPC/PIL to include seizure-related events; this was not known at the time of the 2008 materials and would not have changed the decision.

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