Posted by: Emily Stern, Mailonline Health Reporter
11:41 October 29, 2023, updated 12:13 October 29, 2023
Is your nose stuffy? Don’t rely on common over-the-counter medications.
That’s the conclusion, anyway, from U.S. health advisers who say dozens of cold and flu medications are virtually useless nasal decongestants.
Oral medicines containing phenylephrine could be pulled from shelves on the other side of the Atlantic, in a historic move that will send shockwaves through the multi-million pound industry.
But Brits battling sinuses this winter can also buy the same seemingly useless products here.
Brands such as Sudafed, Benadryl, Lemsip, and Beechams all sell this drug.
Own brand versions such as Boots and LloydsPharmacy are also available.
Many products are sold with other active ingredients, such as paracetamol, which can treat symptoms that usually coincide with nasal congestion.
MailOnline has compiled a complete list of all phenylephrine-containing oral medicines sold in the UK. App users, click here to view.
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A ruling last month by the Food and Drug Administration’s (FDA) special advisory committee, which oversees drug use in the United States, found that phenylephrine is “ineffective” at standard or even high doses when taken in pill or liquid form. ” was the verdict. .
But in the form of a nasal spray, phenylephrine does appear to be effective, reviewers say, because it lands almost where all effective drugs are needed.
“However, decongestant sprays are effective and work within minutes, and decongestion lasts for eight hours.”
Professor Ron Eccles, who ran Cardiff University’s Common Cold Center until he retired from the university in 2017, told MailOnline:Henylephrine is not effective as a nasal decongestant when taken orally because it is metabolized in the intestines and liver before reaching the nose.
“My view is that phenylephrine products should be discontinued in the UK as they are not effective in relieving nasal congestion.
“However, decongestant sprays are effective and work within minutes, and decongestion lasts for eight hours.”
The manufacturer claims that phenylephrine relieves nasal congestion by reducing the swelling of the small blood vessels inside the nostrils, creating more space for air to pass through.
But the FDA concluded that with oral ingestion, the most common approach, much is lost along the way from the stomach to the nose, meaning that not enough of it reaches the nose to have a significant effect. I attached it.
When taken as a nasal spray, the medicine is delivered directly to the nose.
Despite questions about its effectiveness, the price of oral medications containing phenylephrine has increased significantly over the past two years.
Earlier this month, an analysis of pricing data from 10 retailers was conducted by Which? It turns out that the price of many products has doubled.
Lemsip’s flagship dissolvable cold and flu sachets have increased from £3.50 to £5.50 in Asda and Morrisons, a 57 per cent increase in price.
Lemsip Max Day/Night Cold and Flu Relief Capsules have also increased in price by 57% at Morrisons, rising from £3.50 in 2021 to £5.50 in 2023.
Sudafed nasal obstruction and sinus capsules increased by 64% at Waitrose from £3.20 in 2021 to £5.25 in 2023.
The company’s Sinus Max Strength capsules saw the biggest price increase of 86% at Asda, selling for £5 this year, up from £2.69 in 2021.
The NHS watchdog, the National Institute for Healthcare Excellence (Nice), advises on all oral nasal decongestants.
“Although it may relieve nasal congestion in the short term, the effects do not last more than a few days and the benefits are relatively small,” the magazine advises.
Phenylephrine is not specifically mentioned in the guidance, except to later say it should not be given to children under 6 years of age.
A 2008 review by the MHRA found little evidence that they were effective in children. However, we recognize that like any medication, it can cause side effects.
Dr Alison Cave, the MHRA’s chief safety officer, told MailOnline: “Patient safety is our number one priority.” When approving a medicine, all available data is carefully considered, and we continue to closely monitor the safety and effectiveness of all medicines after approval to ensure that the benefits outweigh the risks. .
“We have not identified any new safety concerns regarding products containing phenylephrine and they can continue to be used as directed.”
“If you have concerns about any medication you are taking, please seek advice from your health care professional.”
The Proprietary Association of Great Britain (PAGB), which represents companies that make over-the-counter medicines, also said patients should not be concerned about the FDA’s ruling.
Michelle Riddals, the group’s chief executive, told MailOnline: “Consumer safety is a top priority for our members, including manufacturers of products containing phenylephrine.”
“Products containing phenylephrine sold over the counter here are combined with other active ingredients to provide the best possible symptom relief.
“These products form part of our established cough, cold and flu protection range in the UK.
“This will ensure these medicines are available and easily accessible, enabling consumers to self-care and treat winter illnesses at home, at a time when the NHS is under tremendous pressure. .”
A spokesperson for the British Retail Consortium told MailOnline: “Retailers will comply with all guidance from the MHRA on matters relating to the sale of medicines.”
A Superdrug spokesperson said: “The UK regulator, the MHRA, has not changed its position on phenylephrine and, as always, we will continue to monitor their recommendations and guidance.”
But the FDA’s own ruling on phenylephrine is not the first time questions have been raised about the effectiveness of over-the-counter cold medicines.
In 2014, the Cochrane Institute, which conducts the “gold standard” of evidence-based reviews, found that in the UK “there is no sufficient evidence for or against the effectiveness of over-the-counter medicines for acute cough”. . The drugs included included phenylephrine.
The FDA’s ruling on phenylephrine does not concern pseudoephedrine, another popular nasal decongestant.
Use of phenylephrine has skyrocketed since 2008, when products containing pseudoephedrine were banned in the UK to prevent criminals from turning it into the illegal drug stimulant.
It is illegal to sell or supply products containing more than 720mg of pseudoephedrine to British people without a prescription.
But in February, the MHRA announced it was “considering the available evidence” to see whether the sales rules needed to be changed again following safety concerns.
In very rare cases, drug watchdogs have warned that this drug can cause posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
The European Medicines Agency (EMA) is conducting its own investigation into the drug’s side effects.
The EMA is expected to publish its investigation recommendations in December. The MHRA told MailOnline it could not share its timescale.
In March, Britain’s medicines watchdog ordered around 20 over-the-counter cough medicines, including Day and Night Nurse and Boots Day Cold and Flu Relief, to be withdrawn from the market. This was in response to the
Evidence has been found that pholcodine, found in cough syrup, can cause allergic reactions in rare cases when users undergo surgery and require general anesthesia with the use of muscle relaxants.
While stressing that such reactions are incredibly rare, occurring in about 1 in 10,000 cases, the review notes that the benefits of cough and cold medicines containing pholcodine are “very rare. “This does not outweigh the increased risk of anaphylaxis.”