Dozens of popular cold and flu medicines should be removed from UK shelves because they don’t work, experts urged today.
Yesterday, US health officials proposed phasing out oral medications containing the decongestant phenylephrine, fearing they would be “ineffective” and a waste of US money.
If accepted, it could lead to popular over-the-counter tablets and pills being discontinued across the Atlantic, a move that would send shockwaves through the multi-billion dollar industry.
Now experts are calling for the same to happen in Britain, arguing that British customers are being misled by the pharmaceutical companies behind the ‘useless’ drugs – including Sudafed, Benadryl, Lemsip and Beechams.
But British regulators are refusing to take action, claiming ‘no new safety issues have been identified’.
Dr. Leyla Hannbeck, chief executive of the Independent Pharmacies Association, told MailOnline: ‘It is time for our regulators to step in and provide advice to help all pharmacists make the rightly informed professional decision.
‘The debate over the effectiveness of phenylephrine as an oral decongestant has been going on for some time and the science now appears to prove that it is ineffective, while there are plenty of other products available for nasal congestion.’
Brands including Sudafed, Benadryl, Lemsip and Beechams all sell orally taken medicines containing phenylephrine for almost £5 in Britain
Yesterday, US health officials proposed a complete phaseout of oral medications containing phenylephrine, citing concerns that they would be “ineffective” decongestants.
The concern relates specifically to oral formulations of phenylephrine and not to nasal sprays containing the ingredient, which cost around £5.
Professor Ron Eccles, who led the Common Cold Center at Cardiff University before retiring in 2017, also previously told MailOnline: ‘When taken orally phenylephrine is an ineffective decongestant because it is metabolized in the intestines and liver before reaching the nose.
‘That’s my opinion [oral] Phenylephrine products should be discontinued in Britain as they do not cause any decongestion.
‘However, nasal decongestant sprays are effective and work within minutes and the decongestant effect lasts for eight hours.’
Manufacturers claim that phenylephrine relieves stuffy noses by reducing the swelling of the small blood vessels in the nostrils, allowing more room for air passage.
NHS watchdog, the National Institute for Health and Care Excellence, states orally administered decongestants ‘can relieve a stuffy nose in the short term’.
Manufacturers claim that phenylephrine relieves nasal congestion by reducing the swelling of the small blood vessels in the nostrils, making more room for air to pass through
The concern relates specifically to oral formulations of phenylephrine and not to nasal sprays containing the ingredient, which cost around £5.
However, this effect “does not last more than a few days and the benefit is relatively small.”
Other reviews have found that phenylephrine only appears to work in nasal spray form, as it delivers the drug directly into the nose.
But the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medicines used in Britain, today confirmed it had not reviewed the ingredient because ‘no new safety concerns have been identified’.
Dr. Alison Cave, MHRA chief safety officer, told MailOnline: ‘Patient safety is our top priority.
‘All available data is carefully considered when authorizing a medicine and we continue to closely monitor all medicines for safety and effectiveness post-authorisation to ensure that the benefits outweigh any risks.
‘No new safety concerns have been identified with products containing phenylephrine and people can continue to use the product as directed.
‘If you have any concerns about any medicine you are taking, please seek advice from a healthcare professional.’
The US Food and Drug Administration began reviewing the use of phenylephrine in March 2023.
But the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medicines used in Britain, today confirmed it had not assessed the ingredient as ‘no new safety concerns have been identified’.
Yesterday, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “The FDA’s role is to ensure that drugs are safe and effective.
“Based on our review of the available data, and in accordance with the advisory committee’s advice, we are taking this next step in the process of proposing to remove oral phenylephrine because it is not effective as a nasal decongestant.”
This is currently only a ‘proposed order’ and will have no immediate impact on the medicines.
The FDA is now seeking public opinion on this issue.
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 give manufacturers “additional time to reformulate or remove from the market their phenylephrine-only products.”
They added: ‘The proposed order is based on effectiveness concerns, not safety concerns.’
However, the FDA’s phenylephrine proposal isn’t the first time questions have been raised about the effectiveness of over-the-counter cold remedies.
In 2014, the Cochrane Institute, which conducts the ‘gold standard’ of evidence-based reviews, found that there was ‘no good evidence for or against the effectiveness of over-the-counter medicines in acute cough’ in Britain.
Phenylephrine medications were among the included medications.
In 2015 a study Sponsored in part by New Jersey-based pharmaceutical company Merck & Co. found that the 10-milligram dose, as well as the 20, 30, or 40-milligram doses, were “not significantly better than placebo in relieving nasal congestion” in a sample of 539 adults .