FDA Panel Says Ingredient in Cold Medicine Is Ineffective


Advisors for the US Food and Drug Administration (FDA) are sniffing their noses at a popular decongestant they claim doesn’t actually relieve the symptoms of a common 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 should be pulled from the shelves.

The FDA must now determine whether they want to follow the panel’s recommendation. This major decision would mean companies such as Procter & Gamble and Johnson & Johnson would have to pull many of their products labeled “PE” out of drugstores.

“I think there’s a safety issue there,” Dr. Paul Pisaric of Archwell Health in Oklahoma told The Los Angeles Times. “I think this is a done deal as far as I’m concerned. It doesn’t work.”

A brief 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 companies responded by replacing pseudoephedrine with a safer ingredient called phenylephrine. Customers could still buy products containing pseudoephedrine, but it was placed behind the counter at pharmacies and, in many cases, required a prescription from a doctor. Drugs with names such as Sudafed PE are much easier to purchase, making up the bulk of the $2.2 billion market for oral decongestants.

But doctors and concerned citizens 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 answer a single question: “Do the current 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 is no more need for further studies. In other words, there decision was final.

“We really should not have products on the market that are not 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. But the oral versions, such as pills and syrups, not so much. Why? Some researchers believe that phenylephrine is metabolized by our bellies so well that not enough makes it into our bloodstream and up to our noses.



Source link: https://www.entrepreneur.com/business-news/fda-panel-says-ingredient-in-cold-medicine-is-ineffective/458944

Sponsors

spot_img

Latest

A Love Note to Those Who Are Suffering

As a mother of two children who inhabit my entire heart and soul, I cannot imagine the anguish, fear, and horror of Palestinian...

Powercast’s Ubiquity uses RF to charge devices wirelessly

Connect with gaming and metaverse leaders online at GamesBeat Summit: Into the Metaverse 3 this February 1-2. Register here. Powercast has unveiled its Ubiquity...

USWNT newcomer Savannah DeMelo’s journey will come full circle at World Cup

She played volleyball and basketball for fun. “I wasn’t that great,” she said. She gravitated to soccer for the team aspects, for the...

Google Wallet now has beta support for state IDs starting with Maryland

Maryland was one of the first states to make state IDs available on Apple’s Wallet app for iPhones, and now Google is beta...

France 0-0 Poland – World Cup 2022 LIVE: Kylian Mbappe and Robert Lewandowski face off as last-16 clash underway

France and Poland clash in the last 16 of the 2022 World Cup – and you can follow all the action live on...