By Mary Lloyd, ABC News
A box of Sudafed PE sinus pressure and pain medicine containing phenylephrine is displayed for sale. Photo: PATRICK T. FALLON / AFP
An Australian law firm has filed a class action against global pharmaceutical giant Johnson & Johnson, accusing it of selling medicines known to be ineffective.
Lawyers at JGA Saddler allege the company falsely stated medications such as Codral Day and Night, Sudafed PE and Benadryl PE relieve congestion.
The action relates to tablets containing phenylephrine, a substance which the US Food and Drug Administration (FDA) last year declared was not an effective nasal decongestant when taken in tablet form.
Johnson & Johnson's advertising for Codral Day and Night states, "Phenylephrine helps to relieve blocked and runny noses".
Similarly, the packaging for Sudafed PE refers to phenylephrine as a "nasal decongestant" and the medication's website says it "provides fast, powerful relief from sinus pressure and nasal congestion".
However, Brisbane ear, nose, and throat specialist Dr Jo-Lyn McKenzie said, "The data around phenylephrine is that it's not effective when it's taken orally".
McKenzie said phenylephrine was an effective decongestant when used as a nasal spray.
"It's incredibly effective when it's applied inside the nose," she said.
Dr Mckenzie said the problem with phenylephrine was that it was inactivated when swallowed and didn't have enough clinical effect.
She said the substance began to be used in cold and flu medication after regulations were introduced to make it harder to buy pseudoephedrine.
In 2006, pseudoephedrine was taken off the shelves and put behind the counter at pharmacies, because it was being used to produce methamphetamine and sold as the drug ice.
When the sale of tablets containing pseudoephedrine was restricted, Johnson & Johnson replaced the ingredient with phenylephrine so they could continue selling the products at pharmacies, supermarkets and petrol stations.
McKenzie said the result was people looking for relief from congestion were choosing ineffective products when better products were available.
"They use that treatment as an alternative to medications that do work," she said.
Rebecca Jancauskas. Photo: Supplied via ABC News
Lawyer Rebecca Jancauskas said consumers expected these products to alleviate common symptoms of colds and flu, such as a blocked nose or sinus congestion.
"Many consumers report to us feeling duped, feeling misled by a company that they've trusted for many years."
Jancauskas said many of the products containing phenylephrine were little more effective than paracetamol, which some of the products also contain.
A packet of 100mg paracetamol tablets sells for around $15. A 48-pack of Codral PE Day and Night which contains 500mg of paracetamol costs $22.99 at a major Australian online pharmacy.
Law firm JGA Saddler is asking any Australian who purchased a Johnson & Johnson oral medication containing phenylephrine to register for the class action.
If the action is successful, anyone who bought the products in question since 2005 could be compensated.
Jancauskas said consumers could receive the value of the products they purchased during that period of time.
"This proceeding is about holding Johnson & Johnson accountable for selling products that don't, and have never, done what they say they'll do on the packet," she said.
"There's a risk that the public loses confidence in medications, when they find out that trusted brand names like Codral, Sudafed and Benadryl are ineffective and that the claims that have been made are simply unsubstantiated."
A spokesperson for the Therapeutic Goods Administration (TGA) said they were aware of last year's proposal by the US FDA to remove oral phenylephrine for symptomatic relief of nasal congestion from over-the-counter use.
"If the FDA proposal is adopted, the supply of oral phenylephrine products for nasal de-congestion in the US would need to cease," the spokesperson said.
The TGA noted that the proposed FDA action was "based on efficacy concerns not safety concerns".
"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 ABC has contacted Johnson & Johnson for comment.
The full list of products included in the class action:
- Codral Cold & Flu
- Codral Cold & Flu + Dry Cough
- Codral Day & Night
- Codral Day & Night + Dry Cough
- Codral Night
- Codral Plus Mucus + Cold & Flu
- Codral Cold & Flu (powder sachet)
- Codral Dry Cough + Cold (liquid medicine)
- Codral Cold & Flu + Mucus Cough (powder sachet)
- Codral Mucus Cough + Cold (liquid medicine)
- Codral Cold & Flu + Mucus Cough
- Codral Decongestant
- Sudafed PE Nasal Decongestant
- Sudafed PE Sinus + Allergy & Pain Relief
- Sudafed PE Sinus + Anti-inflammatory Pain Relief
- Sudafed PE Sinus + Pain Relief
- Sudafed PE Sinus + Pain Relief Day + Night
- Sudafed PE Night
- Benadryl PE Dry Cough & Nasal Congestion
- Benadryl PE Chesty Cough & Nasal Congestion
- Benadryl Mucus Relief Plus Decongestant
- ABC News