ON 20 Dec last year, when big news was starting to get lost in the lead up to Christmas, Brisbane law firm JGA Saddler filed a class action against pharmaceutical giant Johnson & Johnson for allegedly selling "ineffective" cold and flu medicine containing phenylephrine to Australians (PD Breaking News).
The firm said group members in the class action are people who purchased any oral phenylephrine-containing products from 2005 to Dec 2024, and according to JGA Saddler Director, Rebecca Jancauskas, thousands of consumers have responded to the callout.
The next stage in the class action is that Johnson & Johnson is bringing an application to strike out parts of the statement of claim, with the hearing of that application listed for 02 Jun.
Concern over the lack of efficacy for phenylephrine has been circulating since it started being used as a replacement for the decongestant pseudoephedrine in cold, flu and sinus products.
The situation came to a head when the US Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee (NDAC) declared in Sep 2023 that phenylephrine, when taken orally, does not work to relieve nasal congestion.
Class actions similar to the JGA Saddler one have been lodged in the US, where what has been described as an "avalanche of phenylephrine lawsuits" began after the FDA's declaration.
One such case before a federal judge was tossed out of court on the basis that until the FDA's monograph has been amended to remove orally administered phenylephrine as a nasal decongestant active ingredient, the labelling of such products as "effective" is not misleading.
"So, even taking plaintiffs' allegations as true, nothing on the labels was false or misleading," the judge wrote.
"Unless and until the FDA amends the monograph in response to the NDAC's findings, it is not misleading to state that phenylephrine is an effective nasal decongestant."
The FDA has proposed making these changes to OTC Monograph M012, and invited stakeholders to submit comments on the proposal, with a closing date of 07 May 2025.
In the event that the proposal is made final, there is likely to be grace period for sponsors to remove their product from the market or reformulate, especially since regulators in other regions will probably follow suit.
At least one US pharmacy chain, CVS, has preemptively removed products that contain oral phenylephrine as a single active ingredient, but has left combination products that also contain analgesics and/or antihistamines on shelves for now.
In Australia, a spokesperson for the TGA told Pharmacy Daily it actively monitors the actions taken by other comparable overseas regulators and is aware of the FDA's ruling that phenylephrine is ineffective.
"At this time, while the TGA does not have current plans to conduct a review of the effectiveness of oral phenylephrine, we will continue to monitor the outcomes of the FDA review and consultation," the spokesperson said.
The Pharmacy Guild of Australia told Pharmacy Daily it is also aware of the situation in the US and is monitoring it.
So with the cold and flu season in full swing, where does that leave Australian consumers - and, importantly, pharmacists who are asked to recommend something to relieve symptoms?
While products containing phenylephrine are widely sold in pharmacies, the Pharmaceutical Society of Australia (PSA) Code of Ethics for Pharmacists states that pharmacists should not recommend or support medicines that have no evidence of efficacy.
Professor Andrew McLachlan, Dean of Pharmacy at the University of Sydney, told Pharmacy Daily that phenylephrine nasal sprays are still a good decongestant option.
"Orally administered phenylephrine has a very low bioavailability, meaning the drug does not reach adequate concentrations in the body to be pharmacologically effective," Prof McLachlan explained.
"However, phenylephrine remains an effective decongestant when administered topically directly to the nasal mucosa."
And getting back to where this all began, consumers may not realise that effective products containing pseudoephedrine can still be purchased behind the counter - subject to certain supply restrictions and medical contraindications. KB
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