MHRA publishes latest batch of decisions for complaints about medicines promotion
Results of five investigations into the way medicines are promoted were published by the Medicines and Healthcare products Regulatory Agency this week.
An internet advertisement for NeoClarityn (desloratadine, Schering-Plough)
claimed that the antihistamine had no adverse psychomotor effects, although
its summary of product characteristics lists psychomotor hyperactivity
as a very rare adverse effect. Schering-Plough agreed to withdraw the
advertisement.
Netto
Foodstores agreed to limit the sale of paracetamol tablets to two
packs at a time after the MHRA investigated an allegation that six packs
of 16 tablets had been sold.
Pfizer agreed to strengthen warnings not to drive, operate machinery
or engage in other potentially hazardous activities in advertisements
for Champix (varenicline) after the MHRA’s pharmacovigilance risk
management group received data that confirmed the potential for adverse
effects.
A complaint about a promotional leave piece for Tradorec
XL (prolonged
release tramadol, Recordati) was referred by the MHRA to the Prescription
Medicines Code of Practice Authority because it included purported MHRA
advice on prescribing branded prolonged release preparations.
The MHRA took the view that the claim was misleading, since it had issued
no formal advice. The Association of the British Pharmaceutical Industry’s
code of practice forbids the mention of the MHRA in promotional material
unless required to do so by the MHRA. The PMCPA upheld the
complaint.
The MHRA rejected a complaint about the promotion of Nicotinell chewing
gum (nicotine replacement therapy, Novartis) at football matches, involving
the handing out of free samples.
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