December 19, 2024 #1 Local News, Information and Event Source for the Century City/Westwood areas.

FDA Panel Deems Popular Nasal Decongestant Ineffective, May Impact OTC Medication Market

Unanimous Decision Raises Questions About Phenylephrine’s Efficacy

By Dolores Quintana

A unanimous decision by a Food and Drug Administration (FDA) advisory panel on Tuesday has cast doubt on the effectiveness of phenylephrine, a key ingredient in numerous over-the-counter cold and allergy medications, in alleviating nasal congestion. This is a conclusion that many people who suffer from sinus issues came to long ago. Phenylephrine, used in Sudafed PE, was a substitute for Pseudoephedrine, which has a common illegal and alternative use as an ingredient in the production of methamphetamine. Medicines that contain Pseudoephedrine were removed from over-the-counter sales in 2006. 

The panel’s vote, which specifically addressed the ineffectiveness of oral formulations of phenylephrine, is poised to disrupt the market for over-the-counter (OTC) cold and allergy remedies. These remedies, which predominantly rely on pill forms, are preferred by consumers. Phenylephrine is a common component in medications such as Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion. It stands as the most widely used oral decongestant in the United States, generating nearly $1.8 billion in sales in the previous year, as reported by FDA officials on Monday.

The panel’s vote aligns with the FDA’s comprehensive findings, which indicated that when taken orally, only a minute amount of phenylephrine actually reaches the nasal area to provide congestion relief.

Susan Blalock, an advisory committee member and retired professor at the UNC Eshelman School of Pharmacy in North Carolina, stated, “The evidence is quite compelling that this medication is ineffective. I believe no further data are necessary to support this conclusion.” The FDA must now determine whether to withdraw phenylephrine’s over-the-counter designation as “generally recognized as safe and effective.” This designation typically applied to older drugs, permits the inclusion of an ingredient in OTC products without requiring an FDA application.

Should the designation be revoked, products containing phenylephrine may be removed from store shelves, or manufacturers may need to develop alternative formulations. An FDA spokesperson declined to specify when the agency will make a final decision, though historically, the FDA tends to align with its advisory committees.
Jennifer Schwartzott, a patient representative from New York, commented, “This drug and its oral form should have been removed from the market long ago. The patient community requires and deserves medications that safely and effectively address their symptoms, and I do not believe this medication fulfills that need.”

Related Posts

Celebrate the Holidays in Style at Something About Her’s Ugly Sweater Soiree

December 19, 2024

December 19, 2024

Festive Looks, Limited-Edition Treats, and Holiday Cheer Await Something About Her has special treats this holiday, so it’s time to...

California Governor Declares State of Emergency Amid Bird Flu Outbreak in Dairy Cattle

December 18, 2024

December 18, 2024

Governor Newsom’s Action Expands the State’s Response to the H5N1 Virus Governor Gavin Newsom declared a State of Emergency today...

Krispy Kreme and Lodge Bread Unite for Limited-Edition Hanukkah Sufganiyot

December 18, 2024

December 18, 2024

Only for a Limited Time and in Limited Quantities for This Special Collaboration Krispy Kreme and Los Angeles-based bakery Lodge...

Explore Eastern Mediterranean Flavors: Zaytinya by José Andrés Now Open in Culver City

December 18, 2024

December 18, 2024

Discover Mezze With a California Twist and Rooftop Bar with Tacos Butterfly  Renowned chef José Andrés has brought his celebrated...

Fia Restaurant Honors Veterans with a Special Thanksgiving Lunch in Santa Monica

December 18, 2024

December 18, 2024

Chef Scott Erickson, a Former U.S. Marine, Leads Fia’s Efforts to Give Back This Thanksgiving, Fia Restaurant extended its commitment...

Celebrate Hanukkah with Authors Paul Small and Josh Freeman at Diesel, A Bookstore

December 18, 2024

December 18, 2024

Interactive Event Explores the Deeper Meaning of Hanukkah With Art and Music On Saturday, Dec. 28, at 2:00 p.m., authors...

(Video) The Watermark at Beverly Hills Offers Boutique-Style Living for Seniors

December 17, 2024

December 17, 2024

For More Info, Go To Watermarkcommunities.com For More Info, Go To https://t.co/1KMXcau57L pic.twitter.com/GD2Cu380SJ — CCNewsLA (@CCWNNews) December 18, 2024

Oscar Race Heats Up: 97th Academy Awards Shortlists Revealed by The Academy

December 17, 2024

December 17, 2024

Documentaries, International Films, Blockbusters In 10 Competitive Categories The Academy of Motion Picture Arts and Sciences has announced the shortlists...

Best Christmas Dinners To Go and Very Special Christmas Treats for Your Holiday Celebration

December 17, 2024

December 17, 2024

Where to Order Some of the Most Delicious and Special Treats for Next Week Christmas is approaching soon and just...

(Video) The Willows: 30 Years Going Strong

December 16, 2024

December 16, 2024

Founded in 1994, The Willows Community School, located in Culver City, California, is a Developmental Kindergarten through 8th grade non-profit, co-educational independent school...

Jamie Foxx Injured in Beverly Hills Restaurant Altercation at His Birthday Dinner

December 16, 2024

December 16, 2024

Beverly Hills Police Investigate Battery Incident at Mr. Chow  The Beverly Hills Police Department (BHPD) is investigating an altercation at...

LAPD Confirms Hannah Kobayashi Found Safe After Voluntary Border Crossing

December 16, 2024

December 16, 2024

Customs Officials Report 30-Year-Old in Good Health; Case Closed The Los Angeles Police Department (LAPD) confirmed on Sunday that Hannah...

Los Angeles County Launches Program to Cancel $500 Million in Medical Debt

December 16, 2024

December 16, 2024

Initiative Targets Low-Income Residents with $2 Billion Debt Relief Goal The Los Angeles County Department of Public Health has launched...

41-Year-Old Piano Teacher Arrested for Alleged Child Sexual Assault in Beverly Hills

December 16, 2024

December 16, 2024

Authorities Urge Other Potential Victims To Come Forward as Investigation Continues A 41-year-old piano teacher was arrested earlier this month...

(Video) Discover Seaside Fun With Pacific Park’s Amusement Rides and Games

December 15, 2024

December 15, 2024

For Tickets and More Info, Go To Pacpark.com For Tickets and More Info, Go To https://t.co/HneRcysYh5 pic.twitter.com/3Kh5HoDLDj — CCNewsLA (@CCWNNews)...