Less than 1 percent of the active ingredient in cold and flu tablets enters the bloodstream, causing only a placebo effect, according to a medical professor.
University of New South Wales (NSW) Pharmacology Head Associate Professor Nicola Smith said the oral ingredient, phenylephrine, found in over-the-counter cough and cold medicine to relieve congestion temporarily, does not reach the nose.
The FDA concluded it is ineffective as a nasal decongestant and could ban it. However, they were not concerned about the safety of oral phenylephrine at the recommended dose and did not investigate its effectiveness in nasal spray form.
The administration stated, “Other products contain phenylephrine and another active ingredient (acetaminophen or ibuprofen) that treats symptoms other than congestion like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms.”
Australia Won’t Pull Phenylephrine From Shelves
Contrary to the FDA’s decision, Australia’s Therapeutic Goods Administration (TGA) has no plans to remove the ingredient from the market.
“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,” the spokesperson said.
The University of Sydney Professor Andrew McLachlan said that regulatory decisions for low-risk medicines tend to be slow.
Over-the-Counter Cough Medicine Cancelled: TGA
However, phenylephrine is not the first cold and flu tablet ingredient to raise concerns. Following a TGA investigation, 55 products containing pholcodine found in cough medicines were cancelled from the Australian Register of Therapeutic Goods on Feb. 28.Different to phenylephrine, which relieves nose congestion, pholcodine is an ingredient that suppresses coughs. Used since the 1950s, it is commonly found in cough lozenges and syrups.
“Pholcodine is an opioid medicine that works directly in the brain, suppressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing,” the TGA said.
The decision to cancel pholcodine was based on a review by the European Medicines Agency (EMA) and a study in Western Australia, which showed it posed an increased risk of anaphylactic reactions to some drugs used during general anaesthesia.
In response, the Pharmacy Guild of Australia’s National President, Professor Trent Twomey urged consumers to check if any of their over-the-counter cold and flu medicines contain pholcodine and, if they do, ask their doctor or pharmacist to suggest an alternative treatment.
At the same time, approval for pholcodine to be sold in New Zealand (NZ) will be withdrawn on Jan. 12, 2024.
Medical Journal Warns of Cough and Cold Medicine
Meanwhile, the Medical Journal of Australia (TMJA) highlighted limited efficacy and potentially severe adverse events, including death, associated with over‐the‐counter cough and cold medicine for young children.While reported poisonings of children under six from these products declined following compulsory labelling changes in 2012 and 2020, around 600 exposures of young children, including 75 requiring hospitalisation, were reported yearly.
The authors said the numbers of poisoning incidents fell following efforts from health professionals and public health campaigns to discourage the use of non-prescription cough and cold products.
“Further, many herbal products were launched after 2012 as they could be labelled suitable for young children. These products are generally safe, and overdose does not typically cause toxicity, but evidence for their efficacy is minimal,” a TMJA spokesperson said.
“The continued off‐label use of products for treating coughs and colds in young children suggests that healthcare professionals and the public may underappreciate their risks. This indicates that further education and clinical guidance are needed.”
