Sanofi has fallen foul of Britain’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), after it probed claims made in a recent TV commercial that the pharma’s allergy drug Allevia does not make patients drowsy.
The MHRA, which regulates drugs and drug messaging in the U.K., said that, in fact, this marketing plug was misleading as Sanofi’s own summary of product characteristics for Allevia states drowsiness as a potential side effect.
This stems from a complaint from a member of the public who took issue with a TV ad seen in March in the U.K. for Allevia, which is sold over the counter for hay fever symptoms.
The MHRA said the complainant alleged that they “felt confused” because the advert stated that “Allevia doesn’t make you drowsy” and is “non-drowsy,” whereas of course the leaflet for the drug says that it can in fact cause drowsiness.
The MHRA investigated the situation and agreed with the complaint, saying Sanofi breached its regulations, specifically the regulation that says: “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.”
In a statement, the MHRA said: “We considered that the claims were not consistent with the product’s SPC, which lists ‘drowsiness’ as a potential undesirable effect of treatment.”
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