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LEMSIP and other popular cold and flu tablets should be pulled from Britain’s shelves because they don’t work, experts have said.
The US Food and Drug Administration yesterday proposed removing oral phenylephrine – widely used in cold and cough syrups – as an active ingredient in over-the-counter drugs for nasal congestion.
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Phenylephrine is used in a variety of flu and cold medicines, including popular products such as Benadryl, Advil, and Tylenol.
It is also an ingredient in nasal sprays to treat congestion, but the FDA’s action is only related to orally administered phenylephrine – not the nasal spray form.
A number of experts have called for the oral phenylephrine remedies – including Sudafed, Lemsip and Beechams – to be pulled from Britain’s shelves.
CEO of Independent Pharmacies Association, Dr Leyla Hannbeck, 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 oral phenylephrine remedies are the only ones affected by the current discussion.
Professor Ron Eccles, who used to run the Common Cold Centre at Cardiff University, previously said that phenylephrine was “an ineffective decongestant” when taken orally.
He said that this is 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.,” he said.
But he added that nasal decongestant sprays are effective.
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Today the Medicines and Healthcare products Regulatory Agency (MHRA), Britain’s drug watchdog, said it was not assessing the ingredient.
Chief safety officer Dr Alison Cave said there have been “no new safety concerns identified” with products containing phenylephrine.
The Proprietary Association of Great Britain (PAGB), which represents organisations making medicines available over the counter, said their regulator “has clearly stated that there have been no new safety concerns”.
Last year in the US, an outside panel of experts unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.
The FDA is now seeking public comments on this proposed order.
For now, companies may continue to market drug products containing oral phenylephrine as a nasal decongestant.
However, the FDA said it would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
The Consumer Healthcare Products Association said in a statement that it was “disappointed in FDA’s proposal to reverse its long-established view of oral phenylephrine.”
The association added that it would review the proposed order and submit comments accordingly.
Producers of the oral remedies – including Kenvue, GSK, Haleon, and Procter & Gamble – have been contacted for comment.
Michelle Riddalls, CEO of PAGB, the consumer healthcare association, said: “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.
“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.
“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.
“The medicines regulator in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), is constantly reviewing the safety and efficacy of the products on the market to ensure the benefit and risks are balanced appropriately.
“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.
“If consumers have questions regarding medicines containing phenylephrine, they can speak to their community pharmacist, who is highly trained to offer expert information and advice.”
Mark Burdon, PAGB expert and pharmacist based in Newcastle-upon-Tyne, with 25 years’ experience advising local customers about medicines, said: “We understand that consumers might be concerned or confused about the news on phenylephrine (PE) 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 PE 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 over-the-counter medicines, so if you have any questions, speak to your community pharmacist.”
Dr Alison Cave, MHRA Chief Safety Officer, said: “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.”
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