Lemsip and Beechams are among several common cold and flu remedies that have been deemed as not effective by health specialists.
Experts are proposing to discontinue oral drugs containing the decongestant phenylephrine over concerns they do not work. The popular products under criticism include Sudafed, Lemsip and Beechams.
UK regulators have hit back defending the drugs by saying: “No new safety concerns have been identified”.
Dr Leyla Hannbeck, CEO of Independent Pharmacies Association, said: “It is time for our regulators to intervene and give their guidance to help all pharmacists make the correctly informed professional decision.
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“The debate about the effectiveness of phenylephrine as an oral decongestant has been doing 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.”
Nasal sprays containing phenylephrine are not under criticism, only oral formulations of the drug.
Professor Ron Eccles, who formerly ran the Common Cold Centre at Cardiff University, said: “When taken orally phenylephrine is an ineffective decongestant 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 added: “However, nasal decongestant sprays are effective and work within minutes and the decongestion effect lasts for eight hours.”
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According to manufacturers, phenylephrine can treat a blocked nose as it reduces swelling of the tiny blood vessels that sit inside the nostrils.
NICE have said: “Orally administered decongestants may relieve nasal congestion in the short term.”
Dr Alison Cave, the Medicines and Healthcare products Regulatory Agency (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.”
She added: “If you have any concerns about a medicine you are taking, please seek advice from a healthcare professional.”
Michelle Riddalls, Chief Executive of the Proprietary Association of Great Britain (PAGB), 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.”
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She added: “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.
“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.”
Dr Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, said: “It is the FDA’s role to ensure that drugs are safe and effective.
“Based on our review of available date, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
