As the winter months approach, you might need to reevaluate ways to combat the inevitable cold. In September, an advisory panel to the Food and Drug Administration (FDA) declared that a common ingredient found in over-the-counter (OTC) decongestants, phenylephrine, was proven to be ineffective.
The FDA has not yet stated whether or not they are taking medications off of the market that contain phenylephrine. Phenylephrine is listed in more than 250 popular brands such as versions of DayQuil, Benadryl and Mucinex. A good thing to note is that the ingredient is still effective in nasal sprays, just not in pill or liquid form. If taken orally, phenylephrine is metabolized in the gut and liver before it reaches the bloodstream in sufficient levels to constrict blood vessels and provide relief for congestion. Products containing phenylephrine are considered safe because they still contain active ingredients that do the trick to fight congestion. According to CNBC, “Retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, up 30% from 2021, according to data compiled by FDA staff. Those generated $1.8 billion in sales last year.” Pulling these medications off of the shelves could impact retail pharmacies that make a lot of revenue from selling OTC drugs.
Why did it take so long for the FDA to discover this? Decades of research studies have taken a deep dive into this ingredient and found its failure. According to the Wall Street Journal, “University of Florida pharmacy researchers who reviewed testing of the pills asked the FDA in 2015 to remove phenylephrine from the list of approved over-the-counter medicines.” This request, however, never reached a consensus by the FDA because the petition “[raised] complex issues requiring extensive review and analysis.”
Phenylephrine has been on the market since 1938 but did not undergo serious clinical background checks. It was not until the early 1990s that over-the-counter cold medicines were reviewed by the FDA. “There is no question that regulation of over-the-counter medications was broken for many years,” said Dr. Joshua Sharfstein, a former agency official and vice dean at the Bloomberg School of Public Health at Johns Hopkins.
According to the New York Times, “Nothing will change immediately. F.D.A. officials have to review the panel’s decision, solicit public comments and most likely will give drug makers some time to adjust or swap out ingredients rather than face a decision to strip store shelves of so many consumer staples.”