We all burn money on cold and flu tablets that may not be an effective treatment for nasal congestion

We allocate a significant amount of funds towards the purchase of over-the-counter cold and flu remedies, surpassing £250 million annually in the UK alone, in order to alleviate the discomfort caused by congested nasal passages, irritating coughs, and sore throats.

However, it is possible that we are squandering our financial resources.

A recent decision made by a group of expert advisors to the Food and Drug Administration (FDA), responsible for regulating medication usage in the United States, has reverberated throughout the lucrative cold and flu product industry on both sides of the Atlantic.

After conducting an extensive analysis of long-term data pertaining to the efficacy of widely recognized brands, the panel consisting of 16 experts has determined that phenylephrine, a crucial component found in the majority of over-the-counter oral decongestants available in the United Kingdom, possesses no discernible advantage over a placebo in terms of alleviating nasal congestion and enhancing respiratory function.

The panel’s findings indicate that the oral administration of this medication, which is the prevailing method of consumption, fails to deliver a sufficient amount of the drug to the nasal cavity, thereby rendering its impact on nasal congestion negligible. This is primarily due to a significant portion of the drug being lost during its transit from the stomach to the nose.

In the form of a nasal spray, phenylephrine has been found to be effective in targeting the specific area where it is needed, according to the reviewers. This medication works by temporarily reducing the size of the blood vessels in the nostrils, thereby alleviating nasal congestion and allowing for improved airflow.

However, the evidence presented to the panel suggests that phenylephrine is not effective when taken orally. One panel member expressed their belief that the evidence was quite compelling in demonstrating the ineffectiveness of this medication when consumed in tablet or capsule form.

Currently, the FDA designates phenylephrine as an effective medication. However, this designation may need to be reconsidered if the FDA agrees with the advisory panel’s ruling. A decision from the FDA is expected in the coming months, and if the ruling is upheld, manufacturers may be required to remove their phenylephrine-containing products from pharmacy shelves.

Following the announcement by the FDA panel, the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK stated that consumers can continue to use products containing phenylephrine as directed. However, some experts are predicting that a ban on phenylephrine in the US may also result in the removal of oral medications containing this ingredient from supermarket shelves. This would include not only cold and flu remedies but also tablets for sinusitis and allergy-related congestion.

Phenylephrine, a medication developed almost a century ago, has become a staple ingredient in top-selling oral brands such as Lemsip, Boots Max Strength Sinus Pressure & Pain Relief Capsules, and Superdrug Max Congestion Relief Capsules. Its popularity surged after products containing pseudoephedrine, a more effective rival ingredient, were removed from UK shelves in 2008 to prevent its use in the illegal drug crystal meth. Unlike pseudoephedrine, phenylephrine cannot be converted into crystal meth.

Following the restriction of pseudoephedrine to pharmacy-only sales, the use of phenylephrine in over-the-counter brands increased significantly. However, despite its widespread use, concerns have been raised about the efficacy of phenylephrine when taken orally. Experts who have lobbied the FDA to remove the drug from the market have scrutinized the data used for its approval in the 1970s and found that some of the information submitted had not been peer-reviewed. Moreover, modern software analysis of the data suggests that phenylephrine is no more effective than a placebo.

Although concerns about the drug were first raised 30 years ago, the FDA reviewed the evidence in 2005 and deemed the drug to be “weakly active” and, therefore, still worthy of approval. This is not the first time that questions have been raised about the effectiveness of over-the-counter cough and cold remedies. In 2014, a review by the highly respected Cochrane organization found that there was “no good evidence for or against” the use of over-the-counter cough medicines sold in the UK.