Popular Decongestant Medicine Found Ineffective: FDA Document

The cold medicine you rely on doesn’t do what it says on the label, according to the FDA.

Colds, flu, or allergies can send you running to the medicine aisle looking for nasal decongestants that claim to relieve symptoms and unblock a stuffy nose.

But the active ingredient in many of them, called phenylephrine (PE), doesn’t offer any real benefits when taken orally, according to the U.S. Food and Drug Administration (FDA). In fact, it may even cause harm, according to Dr. William Schaffner, an infectious disease specialist and professor at Vanderbilt University School of Medicine.

“I would hope that [the drugs] would be withdrawn because there’s no point in taking ineffective medication,” he told The Epoch Times, noting that phenylephrine is a medication that can increase heart rate and cause problems for some people.

Why Use Phenylephrine?

It began with the fight against methamphetamine trafficking. Since pseudoephedrine can be used in the illicit manufacture of this drug, the FDA responded with the Combat Methamphetamine Epidemic Act, which became law in 2006. It banned the OTC sale of medicines containing pseudoephedrine, ephedrine, and phenylpropanolamine. Customers now must request these medications from pharmacy staff.

This left OTC drugs containing phenylephrine as the only easily accessible option.

While the drug’s safety remains unquestioned, the FDA investigated phenylephrine’s efficacy and determined it simply doesn’t work.

This week, the FDA released a briefing (pdf) of its investigation as background for an advisory committee meeting that will decide whether to revoke oral phenylephrine’s “generally recognized as safe and effective” (GRASE) designation due to lack of efficacy.

The briefing noted there is a reasonable expectation that, when used as directed, the drug should provide clinically significant symptom relief. However, reviewers found oral phenylephrine is not an effective nasal decongestant at either the recommended 10-milligram dose every four hours or at higher 40-milligram doses. An effective oral dose of PE for nasal decongestion is unknown.

Phenylephrine is not the only ineffective OTC medication. Others include:

  • Guaifenesin as a cough medicine used to clear mucus from the airways.
  • Dextromethorphan as a cough suppressant for upper respiratory infections.

FDA Panel Found Clinical Trials Were ‘Problematic’

The FDA also found problems with the clinical trials conducted by drug manufacturers that initially claimed phenylephrine’s effectiveness.

“All of the studies (both positive and negative) were highly problematic in both design and methodology,” the reviewers wrote. “All used a highly variable endpoint (NAR) to study a drug in the setting of a highly variable disease state (the common cold) that is no longer used as a primary endpoint to evaluate congestion in pivotal trials.”

The reviewers said the multiple statistical and methodological flaws in the studies make them “unacceptable” as continued evidence for phenylephrine’s efficacy at recommended oral doses.

According to the FDA, the science has evolved since phenylephrine was first recommended as an oral decongestant. The clinical pharmacology of oral phenylephrine was not fully appreciated initially. This explains why the flawed original studies were once considered adequate to support a finding of efficacy and safety for 10-milligram doses taken orally every four hours.

Scientific Evidence Against PE Goes Back Years

Although the FDA panel’s findings are new, studies as early as 2009 found oral phenylephrine no more effective than a placebo. One study compared pseudoephedrine and phenylephrine. Only pseudoephedrine significantly improved nasal congestion over six hours.

“Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective,” Leslie Hendeles, who holds a doctorate in pharmacy and is a professor of pharmacotherapy and translational research, said in 2015. “Patients who seek an over-the-counter remedy should get what they pay for: an effective and safe alternative to a prescription drug.”
The American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology issued a joint statement (pdf) on this issue in May 2022. “Keeping oral phenylephrine over‐the‐counter does a disservice to patients who might be prone to taking higher doses than recommended due to lack of effect and/or delay their visit to their primary care clinician or a specialist who could help resolve their symptoms,” the statement said.
However, there is evidence that PE is effective when used as a nasal spray.

Sometimes, the Best Medicine Is Time

With a new school year starting, the FDA panel findings are of particular interest to parents. Colder weather brings more colds and flu. It’s essential for physicians to discuss all OTC medications with families when children are sick, Dr. Sharon Nachman, chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital, told The Epoch Times.

“Some may be more effective, and some are less effective,” she said, adding that it is important not to use ineffective ones.

When children are sick, Dr. Nachman recommends parents take a common-sense approach to caring for them. That means focusing on providing fluids to prevent dehydration, giving analgesics to relieve discomfort, and allowing the illness to run its course. “Sometimes nothing can make your child heal faster except some time.”

Important Notice: This article was originally published at www.theepochtimes.com by George Citroner where all credits are due.


The watching, interacting, and participation of any kind with anything on this page does not constitute or initiate a doctor-patient relationship with Dr. Farrah™. None of the statements here have been evaluated by the Food and Drug Administration (FDA). The products of Dr. Farrah™ are not intended to diagnose, treat, cure, or prevent any disease. The information being provided should only be considered for education and entertainment purposes only. If you feel that anything you see or hear may be of value to you on this page or on any other medium of any kind associated with, showing, or quoting anything relating to Dr. Farrah™ in any way at any time, you are encouraged to and agree to consult with a licensed healthcare professional in your area to discuss it. If you feel that you’re having a healthcare emergency, seek medical attention immediately. The views expressed here are simply either the views and opinions of Dr. Farrah™ or others appearing and are protected under the first amendment.

Dr. Farrah™ is a highly experienced Licensed Medical Doctor certified in evidence-based clinical nutrition, not some enthusiast, formulator, or medium promoting the wild and unrestrained use of nutrition products for health issues without clinical experience and scientific evidence of therapeutic benefit. Dr. Farrah™ has personally and keenly studied everything she recommends, and more importantly, she’s closely observed the reactions and results in a clinical setting countless times over the course of her career involving the treatment of over 150,000 patients.

Dr. Farrah™ promotes evidence-based natural approaches to health, which means integrating her individual scientific and clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise, I refer to the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice.

Dr. Farrah™ does not make any representation or warranties with respect to the accuracy, applicability, fitness, or completeness of any multimedia content provided. Dr. Farrah™ does not warrant the performance, effectiveness, or applicability of any sites listed, linked, or referenced to, in, or by any multimedia content.

To be clear, the multimedia content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or seen in any website, video, image, or media of any kind. Dr. Farrah™ hereby disclaims any and all liability to any party for any direct, indirect, implied, punitive, special, incidental, or other consequential damages arising directly or indirectly from any use of the content, which is provided as is, and without warranties.