10 September 2014: advert for Helicobacter Test INFAI
Published 15 October 2014
© Crown copyright 2014
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A healthcare professional complained to MHRA about an advert for Helicobacter Test INFAI (13C-urea). The complainant was concerned that the company literature claimed a new Infai breath test meant there was no need to discontinue proton-pump inhibitors (PPIs) for 2 weeks. The complainant considered there was a risk that GPs might prescribe the test without the associated test-meal, which could result in false negatives in patients on PPIs.
MHRA upheld the complaint and considered that the advertising was not consistent with the current summary of product characteristics.
Infai withdrew all references to the ‘new test meal’ and confirmed that all staff members were instructed to advise that PPIs need to be discontinued 14 days before the test.