Common cough and cold remedies are being urgently withdrawn from the market and recalled on the orders of drug regulators.
Twenty products including capsules of Day Nurse and Night Nurse, as well as a host of medicines manufactured by Boots and other brands, are being recalled because of concerns about a “very rare” risk of anaphylaxis.
The concerns relate to products containing pholcodine, a cough suppressant.
Watchdogs said their review had found that pholcodine use, particularly in the 12 months before general anaesthesia involving neuromuscular blocking agents, is a risk factor for developing an anaphylactic reaction.
The European Medicines Agency has already 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.
'Withdrawn as a precaution'
The Medicines and Healthcare Regulatory Agency (MHRA) said: “Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
“The Commission on Human Medicines (CHM), the independent advisory body that provides expert advice on the safety, quality and efficacy of medicines, has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn.”
Dr Leyla Hannbeck, 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. Patients with coughs and colds should contact their local pharmacy for the best advice about the range of alternative products available."
Michelle Riddalls, chief executive of the Proprietary Association of Great Britain (PAGB), the trade association for manufacturers of over-the-counter medicines, said: “We and our members put an absolute priority on patient safety. The risk in people who have used pholcodine is extremely small and the MHRA has taken this decision as a precaution.
“This precautionary measure is an example of the robust safety measures that we have in place in the UK working effectively.
“Our members are working very closely with MHRA, healthcare professionals and pharmacists to ensure that appropriate action is taken.
“Pholcodine-containing products have only been available for purchase in pharmacies and if people have any questions pharmacists are well placed to give advice and recommend alternative products.”
Other medicines reviewed
Health watchdogs are already reviewing the safety of another group of over-the-counter medicines, including Sudafed and Day Nurse, amid concern about links to rare brain disorders.
The MHRA is reviewing the available evidence on potentially serious side effects linked to medicines containing pseudoephedrine.
It came after the European Medicines Agency (EMA) launched a review, following concerns over the risk of two conditions that affect blood vessels in the brain and can cause major and life-threatening complications.
Medicines with pseudoephedrine, which are taken orally, are used to treat nasal congestion resulting from a cold, flu or allergy and work by stimulating nerve endings to release noradrenaline, which causes the blood vessels to constrict.
The drug is contained in a host of over-the-counter medicines, including Sudafed, Day Nurse, Nurofen Cold and Flu and some Benylin products.
The medicines are known to increase the risk of heart conditions and strokes, with restrictions and warnings already included in the medicines’ product information.