The FDA is now announcing that an ingredient in many cold and allergy medications, phenylephrine is no more effective than placebo. This story gets complicated, but I know that, for myself, phenylephrine ABSOLUTELY works to combat nasal congestion. But then again, I know I’m not normal (😊).
If the FDA decides to pull this ingredient off the shelves, there will be essentially no appropriate pharmaceutical options for folks with colds (there are some homeopathic remedies, and other options, that of course, conventional practices won’t tell you about).
The FDA bases their evaluations of population effects. If you’re “not normal” (middle of the pack), you might fall outside of the usual recommendations. FeldMed looks at the individual, not the population. This is the basis for “Personalized Medicine” – it doesn’t have to work for everybody – it just has to work for you!
FROM NEWSDAY / BY LISA L. COLANGELO
A decongestant found in popular nonprescription cold medications including some types of Sudafed, DayQuil and Mucinex doesn’t work, according to a panel of experts reviewing the ingredient phenylephrine for the U.S. Food and Drug Administration.
The unanimous vote on Tuesday could lead the FDA to pull medications with phenylephrine from store shelves, if it accepts the findings. Sales of products with the ingredient were worth $1.7 billion in 2022.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, a member of the panel and an allergy specialist at the Saint Louis University School of Medicine.
Findings from recent studies as well as interpretation of older data, shows phenylephrine is not effective, said Dr. David Rosenthal, attending physician at the division of allergy/immunology at Northwell Health.
“Science progresses over time, and even though it was approved as being effective in the 1970s, it doesn’t meet the current standards for effectiveness,” he said. “This was typically used as a medication that shrank blood vessels in the nose so people would not be as congested.”
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Members of the FDA’s Nonprescription Drug Advisory Committee had been convened to examine data and help determine whether oral phenylephrine is an effective nasal decongestant. The review did not include nasal sprays with phenylephrine.
The debate over the effectiveness of phenylephrine has gone on for over a decade, led by some medical experts and researchers. But sales of products containing the ingredient are strong, especially during the cold and flu seasons. More than 242 million bottles/packages of over-the-counter cough, cold, allergy oral medications with phenylephrine were sold in retail stores in 2022, according to an FDA briefing document.
FDA reviewers said the research shows how quickly phenylephrine is metabolized when taken orally, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays or drops.
Rosenthal said people suffering from allergy symptoms are better off addressing symptoms with antihistamines and seeing an allergist. Cold symptoms will improve when the cold virus goes away with the help of rest, nasal saline and drinking warm liquids.
Rosenthal said preventing infections by getting vaccinated against the flu, COVID-19 and RSV is also important.