It’s winter, your nose is runny. But these cold and flu tablets may not help

It’s the middle of a chilly winter of virus soups, runny noses, red eyes and hacking coughs, with many reaching for cold and flu tablets to ease symptoms.

But what some don’t realise is that a common drug used in products to treat blocked noses does not work when taken in tablet, capsule or liquid form.

Phenylephrine, a drug found commonly in cold and flu tablets, has been found to have very low efficacy.Credit: iStock

Last September, an advisory committee to the US Food and Drug Administration (FDA) unanimously concluded that phenylephrine – an active ingredient in cold and flu medication – is not effective as a nasal decongestant when taken orally.

The FDA must now decide whether tablets and capsules containing phenylephrine should be removed from shelves and manufacturers asked to reformulate products, although it stressed there were no concerns about its safety.

Associate Professor Daniel Malone, the pharmacy course director at Monash University, says it has been known for at least 20 years that phenylephrine works no better than a placebo when taken orally.

“I was not surprised at all – the evidence for that has been around for years,” Malone said.

Associate Professor Dan Malone says the evidence that phenylephrine doesn’t work any better than a placebo when taken orally has been around for years.Credit: Luis Enrique Ascui

So why is an ineffective medicine still stocked in pharmacies and supermarkets across Australia?

Australia’s Therapeutic Goods Administration (TGA) said it would continue to monitor the outcomes of the FDA review: “At this time, the TGA has no plans to conduct a review of the effectiveness of oral phenylephrine.”

A spokesperson for the Australian regulator said the advisory committee to the FDA made non-binding recommendations, which the FDA generally followed but was not legally bound to do.

“The TGA is not aware that the FDA has identified safety concerns or made a decision that phenylephrine is ineffective,” the spokesperson said.

“Australian legislation requires that the active ingredient is displayed prominently on the main label of the medicine to enable consumers to make informed choices when purchasing over-the-counter medicines.”

Malone, who also works part-time at a community pharmacy, says he will always tell customers they are much better opting for a nasal decongestant.

The FDA’s findings did not apply to the nasal spray version of phenylephrine, which can work well.

“If they request tablets with phenylephrine, I think myself and other pharmacists have a duty of care to tell them it’s not that effective in terms of reducing your runny nose,” he said.

Although pseudoephedrine – another ingredient commonly found in cold and flu medication – is an effective nasal decongestant, it has become more difficult to access in recent times.

Professor Andrew McLachlan, the dean of pharmacy at the University of Sydney, said restrictions were introduced after pseudoephedrine was increasingly being used in the illicit manufacture of methylamphetamine.

“It is available behind the counter in a pharmacy, but the pharmacist needs to make an assessment and capture some information about you before they provide it to you.”

McLachlan said these tougher restrictions had led to pharmaceutical companies replacing pseudoephedrine with phenylephrine in many over-the-counter products.

Professor Andrew McLachlan says medicine regulators move slowly when there is no risk of harm.

He said the assumption was that because phenylephrine was effective when applied topically in a nasal spray it would also work in tablets or capsules.

“But there was really no evidence, and subsequently, they’ve identified that when you do take it orally it doesn’t achieve adequate concentrations in your body to be pharmacologically effective,” McLachlan said.

“So they’ve said it’s no different from a placebo.”

McLachlan said phenylephrine was often combined with other ingredients, such as paracetamol or ibuprofen, which could help with pain or reduce fever.

But he said there were clear questions about the efficacy of products containing phenylephrine.

McLachlan said regulators tended to act faster if there were concerns about a medicine being potentially harmful rather than concerns about its efficacy.

“But of course, if you’re promoting medicine that is not effective, then you could be doing harm because you’re delaying people accessing effective treatment,” he said.

The Pharmacy Guild of Australia said it would be guided by the Therapeutic Goods Administration about whether to remove products containing phenylephrine.

Victorian president of the Pharmacy Guild of Australia, Anthony Tassone.Credit: Arsineh Houspian

“But as a pharmacist, I recommend pseudoephedrine in preference to phenylephrine because it has superior effectiveness,” said the guild’s Victorian president Anthony Tassone.

Associate Professor Nicola Smith, head of pharmacology at the University of NSW, said the TGA was unlikely to act before the US regulator.

She called for a campaign to educate the public that tablets containing phenylephrine are not effective decongestants.

Cold and flu tablets containing phenylephrine do not have the same effect as nasal spray.Credit: iStock

“It doesn’t hurt anyone to take these medicines, but it also costs a fortune to buy them, and it’s not having an effect,” said Smith, who hopes that cold and flu tablets containing phenylephrine will ultimately be pulled from the shelves.

“It’s just unfair to offer them to the public.”

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