Advanz Pharma: Macrobid email claim that “1 in 3 adults will fail” trimethoprim for lower UTI ruled misleading (AUTH/3508/5/21)

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Key facts

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Case	AUTH/3508/5/21
Complainant	General Practitioner (via MHRA referral)
Company	Advanz Pharma Services (UK) Limited
Medicine	Macrobid (nitrofurantoin)
Material	Promotional email “Minimising antimicrobial resistance in lower urinary tract infections” (ADV/MAB/PM/0263)
Main claim at issue	“In the UK, 1 in 3 adults will fail treatment for lower UTI with trimethoprim”
Applicable Code year	2019
Complaint received	07 May 2021
Case completed	20 December 2021
Breach clauses	7.2, 7.4, 9.1
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A general practitioner complained (to the MHRA) about an Advanz Pharma Services (UK) Limited promotional email for Macrobid (nitrofurantoin) titled “Minimising antimicrobial resistance in lower urinary tract infections” (ADV/MAB/PM/0263); the MHRA referred it to the PMCPA.
The email included the claim: “In the UK, 1 in 3 adults will fail treatment for lower UTI with trimethoprim”, referenced to NICE NG109 (2018) and the Scottish One Health antimicrobial use and antimicrobial resistance annual report (2018).
The complainant alleged the evidence was misinterpreted: ~1 in 3 E. coli isolates show in vitro resistance to trimethoprim, but that does not equate to clinical treatment failure; and that NICE indicated similar in vivo success rates across several antibiotics.
Advanz said the email aimed to highlight lower resistance rates for nitrofurantoin vs trimethoprim and argued the resistance data (~30–34%) supported the “1 in 3” framing; however, on re-assessment it accepted that stating resistance rates “will” result in treatment failure did not comprehensively reflect potential in vivo outcomes.
Advanz initiated withdrawal of materials using the claim.

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The Panel ruled the claim “In the UK, 1 in 3 adults will fail treatment for lower UTI with trimethoprim” was misleading because it implied 1 in 3 adults would not respond clinically, which was not supported by clinical data and could not be substantiated.
Breaches were ruled for Clauses 7.2, 7.4 (as acknowledged by Advanz) and 9.1 (high standards).
No appeal.

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