March 2022 - Flarin (ibuprofen) summary report
Published 13 April 2022
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This publication is available at https://www.gov.uk/government/publications/advertising-investigations-march-2022/march-2022-flarin-ibuprofen-summary-report
March 2022 Promotion of Flarin (ibuprofen) by Infirst Limited.
A healthcare professional complained about a TV advertisement reportedly seen on 22 November 2021 and social media advertisements for Flarin (ibuprofen). The complainant alleged that the product claim “unique lipid formulation helps shield your stomach from damage” presented in these advertisements was not supported by robust clinical evidence and was potentially misleading.
MHRA began an investigation and assessed the evidence submitted to us by Infirst Limited in support of the claim; the assessment included medical review. MHRA considered that the claim suggested that the lipid formulation of the medicine provided additional gastroprotective properties compared with other ibuprofen products on the market.
However, a review of the evidence presented in support of the claim did not provide a clinically relevant basis for reduced gastric irritation with Flarin compared with other standard formulations. Therefore, evidence that the pharmaceutical characteristics of the lipid formulation were responsible for a safer profile for the stomach compared to standard formulations had not been adequately provided.
MHRA upheld the complaint based on the view that the claim mentioned in the advertisement was not supported by meaningful clinical evidence and was therefore in breach of regulations 280(2) and 280(3) of the Regulations which provide that:
280.(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.
280.(3) A person may not publish an advertisement for a medicinal product that is misleading.
The company confirmed that they would withdraw the claim and other variations of this claim from promotional materials for Flarin.