Dozens of popular cold and flu remedies should be pulled from Britain’s shelves because they don’t work, experts urged today.
Yesterday, US health officials proposed getting rid of oral drugs containing the decongestant phenylephrine over concerns they are ‘not effective’ and a waste of Americans’ cash.
If accepted, it could see popular over-the-counter tablets and pills discontinued the other side of the Atlantic, in a move that would send shockwaves through the multi-million pound industry.
Now, experts are calling for the same to happen in Britain, arguing that UK customers are being hoodwinked by the drug firms behind the ‘useless’ medicines — which include Sudafed, Benadryl, Lemsip and Beechams.
But UK regulators refuse to take action as they claim ‘no new safety concerns have been identified’.
Dr Leyla Hannbeck CEO of Independent Pharmacies Association told MailOnline: ‘It is time for our regulators to intervene and give their guidance to help all pharmacists make the correctly informed professional decision.
‘The debate about the effectiveness of phenylephrine as an oral decongestant has been going on for some time and science now seems to prove that it is not effective while there are plenty of other products available for nasal congestion.’
The concern is specific to oral formulations of phenylephrine rather than nasal sprays containing the ingredient, which cost around £5.
Brands like Sudafed, Benadryl, Lemsip and Beechams all sell drugs taken orally that contain phenylephrine in Britain for close to £5
Yesterday, US health officials proposed getting rid of oral drugs containing phenylephrine completely over concerns they are ‘not effective’ decongestants.
Professor Ron Eccles, who ran the Common Cold Centre at Cardiff University before retiring from the university in 2017, also previously told MailOnline: ‘When taken orally phenylephrine is an ineffective decongestant because it is metabolised in the gut and liver before it reaches the nose.
‘My view is that [oral] phenylephrine products should be discontinued in the UK as they do not provide any decongestion.
‘However, nasal decongestant sprays are effective and work within minutes and the decongestion effect lasts for eight hours.’
Manufacturers claim phenylephrine eases stuffy noses by reducing swelling of the tiny blood vessels that sit inside the nostrils, making more space for air to pass through.
NHS watchdog, the National Institute for Health and Care Excellence, states orally-administered decongestants ‘may relieve nasal congestion in the short term’.
However, this effect ‘does not extend past a few days, and the benefit is relatively small’.
Other reviews have found that only in nasal spray form phenylephrine does seem to work, as it ensures the drug is delivered straight in the nose.
But, the Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, today confirmed it was not assessing the ingredient, given ‘no new safety concerns have been identified’.
Manufacturers claim phenylephrine eases nasal congestion by reducing swelling of the tiny blood vessels that sit inside the nostrils, making more space for air to pass through
The concern is specific to oral formulations of phenylephrine rather than nasal sprays containing the ingredient, which cost around £5
Dr Alison Cave, MHRA chief safety officer told MailOnline: ‘Patient safety is our top priority.
‘All available data is carefully considered when authorising any medicine and we continue to closely monitor all medicines for safety and effectiveness following authorisation, to ensure the benefits outweigh any risks.
‘There have been no new safety concerns identified with phenylephrine containing products and people can continue to use as directed.
‘If you have any concerns about a medicine you are taking, please seek advice from a healthcare professional.’
The Proprietary Association of Great Britain (PAGB), which represents companies making over-the-counter medicines, also insisted patients should not be concerned by the FDA ruling.
Michelle Riddalls, its chief executive, told MailOnline: ‘Consumer safety is paramount to our members, including those who manufacture products containing phenylephrine.
‘We want to reassure consumers that FDA’s consultation is not relating to a safety issue.
‘The products on the market here, containing phenylephrine, are combined with other active ingredients to provide the best possible symptom relief.
But, the Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, today confirmed it was not assessing the ingredient, given ‘no new safety concerns have been identified’
‘These products form part of a well-established cough, cold and flu offering within the UK.
‘This ensures that these medicines are available and easily accessible to allow consumers to self-care and treat these winter ailments at home at a time when the NHS is under a great deal of pressure.’
‘Our regulator has clearly stated that there have been no new safety concerns identified with phenylephrine containing products and people can continue to use as directed.’
The US Food and Drug Administration began reviewing the use of phenylephrine in March 2023.
Yesterday, Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said: ‘It is the FDA’s role to ensure that drugs are safe and effective.
‘Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.’
This is only a ‘proposed order’ currently and will not have an immediate impact on the medications.
The FDA is now seeking public opinion on the matter.
Only then, if the review finds phenylephrine to be ineffective, will a final order be issued, removing it from over-the-counter medications.
Yesterday, the FDA said it would then ‘provide manufacturers with additional time to either reformulate or remove’ their phenylephrine-only products from the market.
They added: ‘The proposed order is based on effectiveness concerns, not on safety concerns.’
The FDA’s phenylephrine proposal, however, is not the first occasion questions have been raised over the effectiveness of over-the-counter cold remedies.
In 2014, the Cochrane Institute, which carries out the ‘gold standard’ of evidence-based reviews, found there was ‘no good evidence for or against the effectiveness of over the counter medicines in acute cough’ in the UK.
Phenylephrine meds were among the drugs included.
In 2015, a study sponsored in part by the New Jersey-based pharmaceutical company Merck & Co found the the 10 milligram dose, as well as 20, 30, or 40 milligram doses were ‘not significantly better than placebo at relieving nasal congestion’ in a sample of 539 adults.
