Sep 13, 2023 21:00:00

The U.S. Food and Drug Administration's advisory committee has determined that anti-rhinitis ingredients used in commercially available cold medicines and anti-allergy medicines are ``ineffective when taken orally.''

Over-the-counter cold medicines and anti-allergy medicines may contain an ingredient called

phenylephrine , which has the effect of constricting blood vessels, to relieve rhinitis. However, an advisory committee of the U.S. Food and Drug Administration (FDA) concluded that phenylephrine is ``ineffective when administered orally.''

FDA panel says common over-the-counter decongestant phenylephrine doesn't work
https://www.nbcnews.com/health/health-news/fda-panel-says-common-counter-decongestant-phneylephrine-doesnt-work-rcna104424

US FDA panel says popular decongestant used in cold medicines ineffective | Reuters
https://jp.reuters.com/article/usa-health-fda-cough-syrup/us-fda-panel-says-popular-decongestant-used-in-cold-medicines-ineffective-idINL4N3AO3NG

Decongestant ingredient in popular products does not work, FDA concludes | US news | The Guardian
https://www.theguardian.com/us-news/2023/sep/12/decongestant-ingredient-does-not-work-fda-phenylephrine

FDA Committee Votes Unaminously Against Efficacy of Nasal Decongestant Oral Phenylephrine
https://www.hcplive.com/view/fda-committee-votes-unaminously-against-efficacy-of-nasal-decongestant-oral-phenylephrine

Phenylephrine is an adrenergic agonist that has vasoconstrictive effects and is used to increase blood pressure during anesthesia, as well as to suppress swelling and bleeding in the affected area. In addition, in the nose where rhinitis occurs, the blood vessels in the mucous membrane dilate and become swollen, so this medicine has the effect of reducing this swelling and relieving rhinitis.

Phenylephrine is found in nasal sprays that are placed directly into the nose, as well as in a variety of over-the-counter medications taken orally, such as Benadryl , Advil , and Tylenol . However, an FDA advisory panel of outside experts reviewed five studies conducted over the past 20 years and found that phenylephrine is broken down in the intestines and cannot be taken orally in tablet, capsule, or liquid form. It was concluded that the anti-rhinitis effect of the drug was comparable to that of a placebo .

The advisory committee also re-evaluated the findings from the previous FDA approval of phenylephrine's use in over-the-counter drugs, finding inconsistent results, flaws in study design, and data integrity issues. I discovered something. 'In conclusion, we believe that the original study was methodologically unsound and does not meet today's standards. In contrast, the new data suggest that it is not reliable. 'However, we do not think this is evidence that oral phenylephrine is effective as a nasal decongestant.'

'The bottom line is that high-quality research tells the truth about phenylephrine,' said

Leslie Henderes, a professor emeritus at the University of Florida who questioned phenylephrine's effectiveness in 2007 and urged the FDA to remove it from over-the-counter drugs. That's true.'' The advisory committee did not deny the effectiveness of phenylephrine when used as a nasal spray, and it is still considered to be effective when applied directly to the nose.

This is just the advisory committee's conclusion, and the FDA will now decide whether to revoke approval for the use of phenylephrine in over-the-counter drugs. If the FDA removes phenylephrine from its approved list, the sale of over-the-counter drugs containing phenylephrine in the United States may be regulated.

'I think it 's clear that there are better over-the-counter drug options to help patients, and research shows that this... 'There is no evidence that the drug is effective.'

The Consumer Healthcare Products Association , an industry group for over-the-counter drug manufacturers, released a statement just before this FDA advisory committee meeting. Removing phenylephrine from over-the-counter medicines could impede consumer access to over-the-counter medicines, potentially causing patients to delay or forgo treatment, which could have 'significant negative unintended consequences' I'm warning you.

Additionally, the Consumer Healthcare Products Association cited a survey in which ``83% of consumers who took over-the-counter medications containing phenylephrine said the medications relieved nasal and sinus congestion.'' It is argued that it has played an important role in public health. “Oral phenylephrine has been trusted as a beneficial nasal decongestant in American households for decades, and the FDA has repeatedly concluded that this ingredient is safe and effective. 'It has been established by multiple double-blind, placebo-controlled trials, supported by the advisory committee twice in the past, and validated by meta-analyses of relevant clinical studies,' he said, disagreeing with the advisory committee's conclusions.