Promotion of Allevia - Summary Report - August 2022
Updated 8 November 2022
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A member of the public complained about a TV advertisement seen in March 2022 for Allevia (fexofenadine hydrochloride) by Opella Healthcare Ltd who trade as Sanofi. Allevia is available as a medicine on general sale to relieve those aged 12 years or older of symptoms associated with seasonal allergic rhinitis (hayfever).
The complainant alleged that they felt confused because the advert stated that: “Allevia doesn’t make you drowsy” and is “non-drowsy”, whereas the leaflet that accompanies the medicine suggested that the medicine may make someone drowsy.
MHRA upheld the complaint because we considered that the TV advert was in breach of the general principles outlined in regulation 280 of the Human Medicines Regulations 2012, which provide that:
280.— (1) A person may not publish an advertisement for a medicinal product with a marketing authorisation [etc] unless the advertisement complies with the particulars listed in the summary of the product characteristics [SPC].
(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.
(3) A person may not publish an advertisement for a medicinal product that is misleading.
We considered that the claims were not consistent with the product’s SPC, which lists ‘drowsiness’ as a potential undesirable effect of treatment. Furthermore, while the SPC states that it is unlikely the medicine will produce an effect on the ability to drive or use machines, it advises users to check individual response before driving or performing complicated tasks.
We further considered that the claims were misleading and failed to present the product objectively by suggesting that no patient who takes Allevia will experience drowsiness. Consumer selection of the product based on these claims in the advert would be inappropriate because the product may cause drowsiness in some patients who may react differently to the medicine.
Sanofi said that they had taken immediate action to put on hold the use of existing media containing the claims: “non-drowsy” and “it doesn’t make you drowsy”, and confirmed that they would not produce any new materials that contain these claims.