AN INGREDIENT found in popular over-the-counter cold medicines like Sudafed PE and Boots Cold & Flu capsules has been deemed ineffective by a panel of drug experts.
The 16 member panel unanimously decided that phenylephrine is useless when taken in pill or liquid form, as it works no better than a placebo to clear bunged up noses.
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The independent advisory committee reviewed scientific evidence on the ingredient compiled by the US Food and Drug Administration (FDA), and held a two-day meeting on the subject before reaching their ruling.
Multiple studies assessed by the panel showed that phenylephrine is ineffective when taken in pill, liquid or capsule form, as it is metabolised in the gut and liver before it reaches the bloodstream.
This means a very small amount of the drug actually reaches the nose to relieve congestion.
Now the FDA is set to decide whether drugs with the ingredient should be taken off shop shelves.
According to The New York Times, it’s likely medicines such as Benadryl, Mucinex, Sudafed PE and Tylenol could be pulled from stores in the US as manufacturers scramble to formulate alternative formulas without phenylephrine.
A patient representative – and one of the Nonprescription Drugs Advisory Committee panel members – Jennifer Schwartzott, said: “This drug and this oral dose should have been removed from the market a long time ago.
“The patient community requires and deserves medications that treat their symptoms, safely and effectively, and I don’t believe that this medication does that.”
The FDA still notes that pills containing phenylephrine are safe to take – just ineffective when dealing with nasal congestion – and the panel’s ruling didn’t cover nasal sprays with the ingredient.
Meanwhile, the panel’s chair and associate professor of pharmacy at Ohio State University, Maria Coyle, said: “I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.”
Phenylephrine features in decongestants such as Sudafed PE and Benadryl Allergy Plus Congestion.
It’s also one of the ingredients in Nurofen’s Cold & Flu relief medicines, Lemsip sachets and capsules, as well Beechams treatments for cold and flu.
Experts at the Proprietary Association of Great Britain (PAGB) discussed what the American advisory committee’s ruling could mean for UK consumers.
Mark Burdon, PAGB expert and pharmacist based in Newcastle-upon-Tyne, said: “We understand that consumers might be concerned or confused about the recent news on phenylephrine and what this might mean for them and their families, especially at this time of year, with cough, cold and flu season upon us.
“Nasal decongestants containing phenylephrine have been trusted by health professionals and consumers for decades and are still available to help treat symptoms of common respiratory infections, such as cough, cold and flu.
“Local pharmacists are highly trained and have a wealth of knowledge and expertise about overt-the-counter medicines, so if you have any questions, speak to your community pharmacist.”
Meanwhile, PAGB CEO Michelle Riddalls, emphasised that “the way medicines are licensed and supplied here in the UK is different to that in the US and are under a completely different legislative system.”
She added that the UK’s medicines- the Medicines and Healthcare products Regulatory Agency (MHRA) – was “constantly reviewing the safety and efficacy of the products on the market to ensure the benefit and risks are balanced appropriately”.
“Consumer safety is paramount to our members, including those who manufacture products containing phenylephrine,” Michelle went on.
“The products on the market here, containing phenylephrine, are combined with other active ingredients to provide the best possible symptom relief. These products form part of a well-established cough, cold and flu offering within the UK.”
Sadik Al-Hassan – a pharmacist at PillTime Pharmacy in Bristol – previously told Sun Health that medicines with phenylephrine are mild decongestants that most people would purchase in a supermarket.
“By the time they get to a community pharmacy, it is usually due to these preparations not working so we would recommend something stronger or a combined therapy,” he explained.
That might include treatments containing pseudoephedrine or steroid nasal spray, depending on the cause of patients’ congestion, Sadik went on.
You can find pseudoephedrine in products such as Benadryl Allergy Relief, Benylin Day & Night and Boots Chesty Cough & Congestion Relief, according to the NHS.