Phenylephrine is the main decongestant ingredient in soluble and tablet-form cold-and-flu medicines such as Lemsip, Beechams, and Sudafed.<\/p>\n
It\u2019s meant to work by reducing the swelling of blood vessels in the nasal passages.<\/p>\n
Other ingredients, such as paracetamol, help bring down temperatures, and relieve aches and pains.<\/p>\n
<\/div>\n
The FDA said it had come to its conclusion after an \u201cextensive review of available data\u201d.<\/p>\n
The ruling does not affect medicines available in the UK, with the Medicines and Healthcare Products Regulatory Agency\u2019s (MHRA) chief safety officer Dr Alison Cave saying there are \u201cno safety concerns\u201d over phenylephrine products and \u201cpeople can continue to use as directed\u201d.<\/p>\n
A group of advisers to the FDA concluded it was ineffective a year ago after research from the University of Florida showed phenylephrine products were no more effective than placebo pills at relieving symptoms.<\/p>\n
Dr Patrizia Cavazzoni, director of the FDA Centre for Drug Evaluation and Research, said: \u201cWe are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.\u201d<\/p>\n
The decision is not final, it added, which means US retailers can still stock medicines that contain the drug.<\/p>\n
But if it is made final, American stores and websites would be banned from selling medicines containing phenylephrine and pharmaceutical companies would be forced to produce nasal decongestants instead \u2013 or find a different ingredient for oral remedies.<\/p>\n
The US industry body, the Consumer Healthcare Products Association, has said banning oral phenylephrine would have a negative impact on consumers.<\/p>\n
Michelle Riddalls, chief executive of the UK\u2019s Consumer Healthcare Association, who represents UK drug manufacturers, told Sky News: \u201cWe 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.<\/p>\n
\u201cConsumer safety is paramount to our members, including those who manufacture products containing phenylephrine. We want to reassure consumers that FDA\u2019s consultation is not relating to a safety issue.<\/p>\n
\u201cNasal 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.\u201d<\/p>\n
Sky News has contacted Lemsip, Beechams, and Sudafed for comment.<\/p>\n<\/p>\n
This post appeared first on sky.com<\/div>\n","protected":false},"excerpt":{"rendered":"
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