The Active Ingredient in Cold and Flu Tablets is Useless, Medical Professors Say

They say the active ingredient, phenylephrine, causes a placebo effect.

Boxes of over-the-counter cold medication in Milwaukie, Oregon in this file photo. Craig Mitchelldyer/Getty Images

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.

However, she told 2GB radio on Oct. 5, “whenever you take something, particularly that you don’t need, you’re still exposing yourself to the risks of an allergic reaction, or there might be some combined effects with other drugs you’re taking.”

Non-prescription drugs are displayed on a shelf at a pharmacy in New York City. Spencer Platt/Getty Images

It comes after the U.S. FDA (Food and Drug Administration) discussed data about the effectiveness of phenylephrine during a non-prescription Drug Advisory Committee meeting held on Sept. 11-12.

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.”

Phenylephrine replaced pseudoephedrine over concerns it contributed to illegal drug creation when purchased in bulk, pushing it behind counters and requiring the presentation of identification for access.

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.

The logo of the Therapeutic Goods Administration is seen at a COVID-19 vaccines press conference in Canberra, Australia, on May 6, 2021. (AAP Image/Lukas Coch). 

A TGA spokesperson said phenylephrine’s safety and efficacy were documented in standard reference texts, and the perceived effectiveness of medications relieving nasal congestion symptoms can vary between individuals.

“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.

Further, Mr. McLachlan said, TGA approval for complementary and herbal medicines did not mean they always worked effectively, and in case of a cold, he recommends consulting a pharmacist for the best course of action.

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.

“This will align our approach with several other countries, including Australia and the UK, where pholcodine has also been withdrawn,” the NZ Ministry of Health said on Sept. 25.

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.”