Safety fears over cold and cough medicines
Drug regulators take 20 remedies off shelves after concerns they could cause anaphylactic shock
THE public has been told to stop taking 20 common cough and cold medicines over safety fears.
The remedies – including capsules of Day Nurse and Night Nurse, as well as a host of medicines manufactured by Boots and other brands – are being immediately withdrawn from the market on the orders of drug regulators.
The Medicines and Healthcare products Regulatory Agency (MHRA) stressed the risk relates to a “very rare” risk of anaphylaxis, particularly among those who later undergo surgery, and require medicines which are used alongside anaesthetics.
The concerns relate to products containing pholcodine, a cough suppressant. Patients are being told to check the labels of cough medicines at home, and to seek advice from pharmacists about using alternative remedies if required. Experts last night said most coughs would clear up on their own within a couple of weeks.
Anyone undergoing surgery is being urged to tell their anaesthetist if they think they have taken a medicine containing pholcodine.
Watchdogs said their review had found that pholcodine use – particularly in the 12 months before general anaesthesia backed with muscle relaxants – is a risk factor for developing an anaphylactic reaction.
Such agents are used in about half of operations involving a general anaesthetic.
The Commission on Human Medicines, which advised the MHRA, said the absolute risk of anaphylaxis following neuromuscular blocking agents is “very small”, at less than 1 case per 10,000 procedures overall.
The MHRA considered a recent study, which showed that use of pholcodine during the 12 months preceding anaesthesia was “significantly associated” with a four-fold increase in risk.
Data on the risk beyond 12 months was not available, but an early study in Norway suggests that a “very small increased risk may persist for up to three years”.
The European Medicines Agency recently recommended the withdrawal of such products, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu. In the UK recall notice, the MHRA said: “The available data has demonstrated that pholcodine use, particularly in the 12 months before general anaesthesia with NMBAS, is a risk factor for developing an anaphylactic reaction to NMBAS.”
It added: “Given the advice of the CHM and the lack of identifiable effective measures to minimise the increased risk of anaphylactic reactions to NMBAS, pholcodine-containing medicines are being withdrawn from the UK market and will therefore no longer be available in pharmacies.”
The MHRA said that all pholcodinecontaining medicines are “pharmacyonly medicines” which means they will have only been sold or dispensed under the supervision of a suitably trained healthcare professional.
Healthcare workers have been told to stop supplying the products “immediately” and return stocks to the manufacturer. Prof Penny Ward, independent pharmaceutical physician, and Visiting Professor in Pharmaceutical Medicine at King’s College London, said: “Anyone that has any cough or cold remedies in their medicine cupboard should check to see if any contain pholcodine and if so get rid of them.
“Anyone that has taken a cough or cold remedy recently and is going to have a general anaesthetic should tell the doctor/nurse that they might have taken pholcodine – this also applies if the cough medicine was taken anytime within 12 months prior to an anaesthetic procedure in the future.
“Although pholcodine is effective in suppressing cough, most illnesses causing coughs will recover, even if not treated, within 1-2 weeks and other medicines which can sooth cough are available if needed.”
Dr Leyla Hannbeck, the chief executive of the Association of Independent Multiple Pharmacies, said: “Pharmacies across the UK take patient safety very seriously and will be assisting with the recall of these products.”