Scientists Challenge the Efficacy of Phenylephrine Cold Medicines

Leslie Hendeles and Randy Hatton, two determined scientists, have been at the forefront of a campaign against the use of phenylephrine in over-the-counter cold medicines, asserting its ineffectiveness.

Quick Facts

  • Phenylephrine is an ingredient in over 200 over-the-counter decongestants, but recent studies suggest it’s no more effective than a placebo when taken orally.
  • After a petition from Hendeles and Hatton, the FDA’s advisory panel unanimously agreed that oral phenylephrine wasn’t effective in clearing stuffy noses.
  • Major pharmacy chain, CVS Health, has decided to remove products listing phenylephrine as their sole active ingredient from their shelves.

Randy Hatton and Leslie Hendeles, who first crossed paths at the University of Florida four decades ago, have dedicated nearly 20 years to studying the science behind phenylephrine. Their commitment to the cause was fueled by their belief that consumers were being misled by the efficacy of a drug that didn’t deliver on its promises. Their relentless pursuit of the truth led them to gather substantial evidence against the use of phenylephrine in oral medications.

Phenylephrine has been a common ingredient in cold medicines for almost a century. However, studies over the years have consistently shown that when taken orally, it doesn’t effectively clear nasal congestion. This inefficacy is believed to be due to the drug being largely inactivated in the gut and liver before it can enter the bloodstream. Despite this, the drug has remained a staple in many over-the-counter decongestants, leading to billions in sales annually. This discrepancy between scientific evidence and market presence deeply concerned both Hendeles and Hatton, prompting them to take action.

The duo’s dedication wasn’t just limited to their professional lives. Their personal journeys, encompassing marriages, divorces, retirements, and family expansions, were intertwined with their shared mission. Their relentless advocacy, which included publishing studies, writing commentaries, and directly petitioning the FDA, finally saw a significant breakthrough when CVS Health decided to pull products containing only phenylephrine from their shelves.

For Further Reading Phenylephrine is a common decongestant found in many over-the-counter cold medicines. Approved for use almost a century ago, it’s designed to relieve nasal congestion. However, recent studies have shown that when taken orally, it’s no more effective than a placebo. This is believed to be because a significant portion of the drug is inactivated in the gut and liver before reaching the bloodstream. As a result, its efficacy as an oral medication has been called into question by many in the scientific community. [Wikipedia]


Why have Hendeles and Hatton targeted phenylephrine in cold medicines?
They believe that phenylephrine, when taken orally, is ineffective in treating nasal congestion and have gathered evidence to support this claim.

What was the FDA’s response to their findings?
An advisory panel to the FDA, after reviewing the studies, unanimously determined that oral phenylephrine wasn’t effective in clearing stuffy noses.

How have pharmacies reacted to these findings?
CVS Health, one of the nation’s largest pharmacy chains, has decided to remove products that list phenylephrine as their only active ingredient.

Original article source: The Wall Street Journal

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