Advisors for the US Food and Drug Administration (FDA) are sniffing their noses at a preferred decongestant they claim doesn’t actually relieve the symptoms of a standard cold.
On Tuesday, advisors to the FDA unanimously voted that phenylephrine, or “PE,” found in oral versions of Sudafed, Allegra, and Dayquil, is ineffective and must be pulled from the shelves.
The FDA must now determine whether or not they wish to follow the panel’s advice. This major decision would mean firms resembling Procter & Gamble and Johnson & Johnson would need to pull lots of their products labeled “PE” out of drugstores.
“I feel there is a safety issue there,” Dr. Paul Pisaric of Archwell Health in Oklahoma told The Los Angeles Times. “I feel this can be a done deal so far as I’m concerned. It doesn’t work.”
A transient history of phenylephrine
In 2006, President Bush signed an act banning over-the-counter cold medicines with pseudoephedrine sales. The decongestant effectively clears stuffy noses but was also used in the illicit market to make methamphetamine.
Drug firms responded by replacing pseudoephedrine with a safer ingredient called phenylephrine. Customers could still buy products containing pseudoephedrine, but it surely was placed behind the counter at pharmacies and, in many cases, required a prescription from a health care provider. Drugs with names resembling Sudafed PE are much easier to buy, making up the majority of the $2.2 billion marketplace for oral decongestants.
But doctors and anxious residents have questioned PE’s effectiveness for years.
Panel votes no
Responding to continuing criticism of phenylephrine by doctors and citizen petitions, the Food and Drug Administration assembled a committee of experts to research whether the ingredient works.
The committee was asked to reply a single query: “Do the present scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant?”
Its unanimous answer: “No.”
The committee also agreed that there isn’t any more need for further studies. In other words, there decision was final.
“We actually shouldn’t have products in the marketplace that aren’t effective,” committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy told CNN.
Nasal sprays are okay
One caveat to the FDA committee’s recommendations. Drugs with phenylephrine that come as nasal sprays have been shown to be effective against congestion. However the oral versions, resembling pills and syrups, not a lot. Why? Some researchers imagine that phenylephrine is metabolized by our bellies so well that not enough makes it into our bloodstream and as much as our noses.