Last Updated on December 31, 2023 by The Health Master
Cold medicine
In a pivotal development, a panel of external experts advising the U.S. Food and Drug Administration (USFDA) raised concerns about the efficacy of orally administered over-the-counter (OTC) cold medicine containing phenylephrine.
This particular ingredient is widely used in various cough and cold syrups.
Panel Votes Unanimously Against Phenylephrine as Nasal Decongestant
During the session, the panel members voted unanimously against considering orally ingested phenylephrine as an effective nasal decongestant.
Additionally, they emphasized that further trials were unnecessary to establish its efficacy in this regard.
This significant decision could potentially lead to the removal of oral phenylephrine, a key component found in popular products such as Benadryl, Advil, and Tylenol, from the list of USFDA-approved OTC ingredients.
Consequently, its availability for sale in the United States might be restricted.
It is worth noting that while the USFDA often follows the recommendations put forth by its expert panels, it is not legally bound to do so.
Patient Safety Advocacy
Jennifer Schwartzott, a member of the USFDA panel, expressed her stance, stating, I don’t think this drug provides what the patient population needs and deserves, which is to safely and effectively address their symptoms.
This sentiment emphasizes how crucial it is to make sure that consumers’ prescriptions are safe and effective.
Manufacturer Response
As news of the panel’s decision broke, Kenvue, the producer of Tylenol, and GSK, the company behind Advil, had yet to issue official statements in response to requests for comments from Reuters.
Background: Phenylephrine vs. Pseudoephedrine
Phenylephrine emerged as a replacement for pseudoephedrine in numerous non-prescription medicines used as allergy and cold medicine.
This transition occurred after pseudoephedrine faced restrictions due to reports of its misuse and abuse.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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