A spokesman for the Australian regulator said recommendations made by the FDA advisory committee are not binding and the FDA generally follows them but is not legally required to do so.
“The TGA is not aware that the FDA has identified any safety concerns or determined that phenylephrine is ineffective,” the spokesman said.
“Australian law requires that active ingredients must be displayed prominently on a medicine’s main label to enable consumers to make informed choices when buying over-the-counter medicines.”
Malone, who works part-time at a local pharmacy, said she always tells customers that decongestants are a much better option.
The FDA’s findings did not apply to the nasal spray version of phenylephrine, which may be effective.
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“When a patient asks for a tablet that contains phenylephrine, I think I and other pharmacists have a duty of care to let them know that it’s not going to be as effective at controlling a runny nose,” he said.
Pseudoephedrine, another common ingredient in cold and flu medications, is an effective nasal decongestant but has become harder to come by these days.
Professor Andrew McLachlan, dean of the University of Sydney’s school of pharmacy, said the restrictions were introduced because pseudoephedrine was increasingly being used to illegally manufacture methylphetamine.
“It is available over the pharmacy counter, but a pharmacist must make a diagnosis and collect patient information before providing it.”
McLachlan said these stringent regulations have prompted drug companies to substitute phenylephrine for pseudoephedrine in many over-the-counter medications.
Professor Andrew McLachlan said the medicines regulator would move slowly where there was no risk of harm.
He said that because phenylephrine is effective when applied topically as a nasal spray, he speculated that it might also be effective in tablet or capsule form.
“But there was actually no evidence and it was subsequently discovered that it did not reach sufficient concentrations in the body to have any pharmacological effect when taken orally,” McLachlan said.
“That’s why they said it was no different from a placebo.”
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Mr McLachlan said phenylephrine was often combined with other ingredients such as paracetamol or ibuprofen, which can help relieve pain and reduce fever.
But he said there are obvious questions about the effectiveness of products that contain phenylephrine.
McLachlan said regulators tend to act more quickly when there are concerns about a drug’s potential harm, rather than concerns about its effectiveness.
“But of course, promoting ineffective drugs can cause harm by delaying people’s access to effective treatment,” he said.
The Australian Pharmaceuticals Guild said it would follow guidance from the Therapeutic Goods Administration on whether to remove products containing phenylephrine.
Anthony Tassone, Victorian president of the Australian Union of Pharmacists.credit: Alcine Hauspian
“But as a pharmacist I would recommend pseudoephedrine over phenylephrine because it is more effective,” the union’s Victorian president, Anthony Tassone, said.
Associate Professor Nicola Smith, head of pharmacology at the University of New South Wales, said the TGA was unlikely to act before US regulators.
She called for a campaign to educate the public that tablets containing phenylephrine are ineffective at relieving stuffy noses.
Cold and flu medications that contain phenylephrine do not have the same effect as a nasal spray.credit: iStock
“These drugs aren’t harming anyone, but they are extremely expensive to buy and ineffective,” said Smith, who hopes that cold and flu medications that contain phenylephrine will eventually be removed from store shelves.
“It’s unfair to expose this to the public.”
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