The most common over the counter medication for congestion doesn’t work.
“America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration (FDA) panel in a unanimous vote on September 12.”
In the early 21st century, pseudoephedrine, commonly known as Sudafed, could be used to make illegal drugs so the passage of Combat Methamphetamine Epidemic Act of 2005 forced all products that had it as an ingredient to be pulled from the shelves. The government restricted the amount you could buy plus they monitored who was buying it and so it became a ‘behind-the-counter’ drug. The cold medicine companies started using phenylephrine (PE) as a replacement, so that you could still buy their products easily over-the-counter (OTC). They claimed it was essentially the same. ($$$)
Researching, I discovered that, according to Analogue-based Drug Discovery Phenylephrine was patented in 1927 and came into medical use in 1938. 1. That’s nearly 100 years. This product has been available and used for ONE HUNDRED YEARS.
Anyway, many of us bought products with this drug because “we trusted the science” but we all soon realized that it really wasn’t the same. I stopped immediately and went the extra mile to get the “controlled substance” and signed my life away when I needed the relief for my congestion. I have allergies so I needed it yearly. Doing that made me feel like a criminal. I hated it but I did it so that I could breathe. The other stuff simply did not work.
One year after the drug companies started replacing pseudoephedrine with phenylephrine, circa 2006, a study was published Oral phenylephrine: An ineffective replacement for pseudoephedrine?. Many more studies and clinical trials happened and many more articles and research findings were published over the years. Yet the FDA allowed this ineffective product to be sold for over 15 years.
Finally, in 2023, more research came to light and this time the FDA voted 16-0 that the drug was ineffective.
BILLIONS of dollars over more than a decade spent every single year on something that does not claim to do…what it says it would do.
“According to the FDA review, 242 million packages or bottles of phenylephrine products were sold in 2022, resulting in $1.76 billion in sales. A little over 50 million packages of pseudoephedrine were sold that same year, resulting in $542 million in sales.”
So much money spent on the “well… it can’t hurt!” type of thinking so many of us do when we get sick.
Because of the CARES Act, the FDA was finally given the resources they needed to assess this drug.
“Changes contemplated by the Agency were primarily delayed by the time and resources needed to fully review the issues. That stated, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, 2020, does provide an updated pathway to issue, revise, or amend OTC monographs by replacing rulemaking with an administrative order process, which will simplify the process of making any contemplated changes to the monograph.”2
Everything always comes down to money. Who has it, who’s paying for it and who is talking the loudest. It is interesting to see how the timeliness of this decision syncs up with upcoming “tripledemic season”.
“Sales of such cold medicines have spiked during the Covid-19 pandemic, particularly during “tripledemic” seasons where cases of the flu and respiratory syncytial virus are also on the rise, like last winter when stores faced shortages and imposed limits on the number of medications consumers could buy (The CDC has already said all three viruses could be dangerous this winter).”
What will science discover next that will cause us to rely more and more on the government? People really need to start looking into alternative doctors and medicines. Truly, “it can’t hurt!”.
Meanwhile, join me as we continue to go Down the Rabbit Hole.
- Fischer J, Ganellin CR (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 541. ISBN 9783527607495.
- FDA Briefing Document
Efficacy of Oral Phenylephrine as a Nasal Decongestant
Nonprescription Drug Advisory Committee Meeting
September 11 and 12, 2023