Over-the-counter cold medications don't work, FDA panel rules
Adding weight to the large body of scientific evidence showing that phenylephrine is as useless as a placebo for nasal congestion, a US Food and Drug Administration (FDA) advisory panel has unanimously declared common oral medications ineffective. It paves the way for these products to be taken off shelves and reformulated.
On September 12, the FDA’s independent Nonprescription Drugs Advisory Committee voted on the direct question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant?”
The 16-person panel, which was assembled to address the issue following ongoing criticism from medical professionals and citizen petitions, as well as research, unanimously voted no. The FDA has since said it will take the panel’s advice into consideration.
Phenylephrine, which is an alpha-1 adrenergic receptor agonist that temporarily constricting blood vessels, has been approved for use as the active ingredient in over-the-counter (OTC) nasal decongestant products since 1976. It’s the key ingredient in 261 OTC products currently, including popular brands such as Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl, which customers can find on grocery and specialty store shelves across the US.
Phenylephrine-containing OTC medicines became more popular during the mid-2000s, when then-president George Bush Jr incorporated The Combat Methamphetamine Epidemic Act of 2005 into the Patriot Act on March 9, 2006, banning the OTC sale of cold medicines that contained pseudoephedrine.
Pseudoephedrine, a less selective agonist than phenylephrine and one that acts on both alpha- and beta-adrenergic receptors, can be used to make methamphetamine. It’s also a much more effective nasal decongestant. While products containing pseudoephedrine are still available 'behind the counter,' with restrictions, phenylephrine medicines have swiftly grabbed the market share.
“The most current estimates of retail sales data are from 2022, when an estimated 242 million bottles/packages of OTC cough/cold/allergy oral products containing PE [phenylephrine] were sold from retail stores,” noted the panel.
This equates to annual sales of around US$1.763 billion, compared to $542 million for pseudoephedrine medicines (at 51 million bottles/packages).
In the 2015 paper published in the journal Annals of Allergy, Asthma & Immunology, researchers concluded: “During a six-hour observation period, a single dose of pseudoephedrine but not phenylephrine resulted in significant improvement in measures of nasal congestion.”
While phenylephrine works by reducing swelling in nasal passages, the issue comes with how little of the ingredient reaches its target. In oral form, phenylephrine is metabolized so efficiently by the gut that only a small amount is released into the bloodstream. Research shows that this remains constant even with safely increased dosage.
However, phenylephrine nasal sprays have proven more effective, delivering the active ingredient straight to its target.
“Oral pseudoephedrine from behind the counter, nasal steroids for allergic rhinitis, and topical decongestants for viral-induced nasal stuffiness are all safe, effective, and available OTC drugs,” stated researchers in the 2015 paper published in The Journal of Allergy and Clinical Immunology: In Practice.
“Patients who seek an OTC remedy should get what they pay for: an effective and relatively safe alternative to a prescription drug,” the researchers also stated.
More recent research has seen scientists be more forthright in urging the FDA to review these popular products.
“Ineffective over-the-counter (OTC) drugs should be removed from the US market,” researchers wrote in their 2022 Annals of Pharmacotherapy paper. “Despite solid research showing that oral phenylephrine is ineffective as a decongestant, the US Food and Drug Administration has failed to respond to a 2015 citizen’s petition to remove it from the OTC nasal decongestant monograph.”
The report from the Nonprescription Drug Advisory Committee can be found here.