Night Nurse among 20 cold remedies taken off the shelves
POPULAR cold and flu remedies are urgently being pulled from shelves over fears they can cause severe allergic reactions.
Twenty products are being withdrawn, including those made by Day & Night Nurse and Covonia – as well as own-brand versions on sale at Boots and Superdrug.
It emerged yesterday that regulators decided to withdraw the medicines from the UK market ‘as a precaution following a review’.
Evidence was found that pholcodine, which is found in cough syrups, could in rare cases cause an allergic reaction in patients who have an anaesthetic that involves the use of a muscle relaxant.
The review concluded that the benefits of pholcodine-containing cough and cold medicines did ‘not outweigh the increased risk of the very rare event of anaphylaxis’.
The European Medicines Agency recommended the products’ withdrawal from the EU in December over similar concerns.
EMA chiefs said data showed that use of pholcodine in the 12 months before general anaesthesia raised the risk of an anaphylactic reaction. ‘It was not possible to identify effective measures to minimise this risk,’ officials said.
The Medicines and Healthcare products Regulatory Agency, which polices UK drugs, was responsible for the review here.
It said there was evidence of an increased risk of anaphylaxis ‘in patients who receive general anaesthesia involving neuromuscular blocking agents during surgery’. The watchdog said adverse cases were ‘very rare’.
The Commission on Human Medicines, which advises the Government on drug safety, efficacy and quality, said there was ‘sufficient overall evidence for an association with pholcodine’.
But it said ‘the absolute risk’ was very small, affecting around one in 10,000 procedures.
Dr Alison Cave of the MHRA said: ‘Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.
‘If you have an operation scheduled using general anaesthesia, tell your anaesthetist if you think you have used pholcodine, particularly in the past 12 months.’
The Therapeutic Goods Administration pulled 55 products from pharmacies in Australia last month amid concerns over pholcodine.
The TGA said it was aware of 50 adverse cases with one death.
‘Cases are very rare’