AN INGREDIENT found in popular over-the-counter cold medicines such as Sudafed PE and Boots Cold & Flu capsules has been deemed ineffective by a group of drug experts.
The 16-member panel unanimously decided that phenylephrine is useless when taken in tablet or liquid form because it is no better than a placebo at clearing stuffy noses.
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Treatments containing phenylephrine are no more effective than placebo in treating nasal congestion, advisory panel findsCredit: Getty
An independent advisory committee reviewed the scientific evidence on the ingredient collected by the US Food and Drug Administration (FDA) and held a two-day meeting on the subject before reaching its decision.
Multiple studies reviewed by the panel found that phenylephrine is ineffective when taken in tablet, liquid or capsule form because it is metabolized in the intestines and liver before it reaches the bloodstream.
This means that a very small amount of the medicine actually reaches the nose to relieve congestion.
Now the FDA will decide whether drugs with this ingredient should be pulled from store shelves.
According to The New York Times, it is likely that drugs such as Benadryl, Mucinex, Sudafed PE and Tylenol could be pulled from US stores as manufacturers scramble to formulate alternative phenylephrine-free formulas.
Patient representative – and one of the council members of the OTC Medicines Advisory Committee – Jennifer Schwartzott, said: “This drug and this oral dose should have been removed from the market a long time ago.
“The patient community demands and deserves drugs that treat their symptoms, safely and effectively, and I don’t believe this drug does that.”
The FDA continues to note that pills containing phenylephrine are safe to take — they’re just ineffective when dealing with nasal congestion — and the panel’s decision did not cover nasal sprays with the ingredient.
Meanwhile, panel chair and Ohio State University associate professor of pharmacy Maria Coyle said, “I think we clearly have better options over the counter to help our patients, and the studies don’t show that it’s an effective drug.”
Phenylephrine appears in decongestants such as Sudafed PE and Benadryl Allergy Plus Congestion.
It is also one of the ingredients of Nurofen cold and flu medicines, Lemsip sachets and capsules, as well as Beechams cold and flu treatment.
Experts at the Proprietary Association of Great Britain (PAGB) discussed what the US advisory board’s decision could mean for British consumers.
Mark Burdon, Newcastle-upon-Tyne-based PAGB specialist and pharmacist, said: “We understand that consumers may be worried or confused by the recent news about phenylephrine and what it could mean for them and their families, particularly at this time of year , the season of coughs, colds and flu is upon us.
“Nasal decongestants containing phenylephrine have been trusted by healthcare professionals and consumers for decades and are still available to treat symptoms of common respiratory infections, such as coughs, colds and flu.
“Local pharmacists are highly trained and have a wealth of knowledge and expertise in over-the-counter medicines, so if you have any questions, please contact your local pharmacist.”
Meanwhile, PAGB chief executive Michelle Riddalls stressed that “the way medicines are licensed and supplied here in the UK is different to the US and under a completely different legislative system.”
She added that Britain’s medicines agency – the Medicines and Healthcare Products Regulatory Agency (MHRA) – “constantly reviews the safety and effectiveness of products on the market to ensure an appropriate balance between benefits and risks”.
“Consumer safety is paramount to our members, including those who manufacture products containing phenylephrine,” continued Michelle.
“The products on the market here, which contain 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 range in the UK.”
Sadik Al-Hassan, a pharmacist at PillTime Pharmacy in Bristol, previously told Sun Health that phenylephrine drugs are mild decongestants that most people would buy from the supermarket.
“By the time they get to the public pharmacy, it’s usually due to the ineffectiveness of these preparations, so we would recommend something stronger or combined therapy,” he explained.
These could include treatments containing pseudoephedrine or a steroid nasal spray, depending on the cause of the patients’ congestion, Sadik continued.
You can find pseudoephedrine in products such as Benadryl Allergy Relief, Benylin Day & Night and Boots Chesty Cough & Congestion Relief, according to the NHS.
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