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.”
The MHRA found that Sanofi’s claims were “misleading” and “failed to present the product objectively by suggesting that no patient who takes Allevia will experience drowsiness.”
It said this meant that consumers who chose this drug based on those false claims in the advert “would be inappropriate because the product may cause drowsiness in some patients who may react differently to the medicine.”
As a result of the probe, Sanofi told the MHRA that it 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 it would not produce any new materials that contain these claims.
Sanofi told Fierce Pharma Marketing in a statement that: “Patient safety is of paramount importance to Sanofi and we worked closely with the Medicines & Healthcare products Regulatory Agency (MHRA) to understand the concerns brought to them by a member of the public. Second generation antihistamines, including fexofenadine, are usually referred to as ‘non-drowsy.’”
Sanofi said it was “well known” that several molecules within this class of antihistamines are capable of crossing the blood-brain barrier and causing drowsiness, but argued that this mechanism “is not common to all the molecules of this class.”
In particular, the pharma argues that fexofenadine “is well known for not being able to cross the BBB and cause drowsiness.”
Sanofi added that while it was “disappointed by the MHRA's decision,” it took “immediate action” to comply and withdraw the existing advertising. “We then worked with both the MHRA and PAGB to agree alternative claims and all future advertising and materials in the UK will be consistent with the summary of the product characteristics (SPC).”