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Opinion: FDA Proposes Removing Sudafed PE and Cold Meds

An advisory committee unanimously decided that oral phenylephrine was ineffective a year ago. But Americans are still buying it

Suzanne B. Robotti

November 21, 2024

0 Comments

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FACT CHECKED opinion

In October 2023, I wrote about the Food and Drug Administration (FDA)’s Nonprescription Drugs Advisory Committee and its unanimous vote that the primary ingredient in Sudafed PE and many other OTC cold medicines, oral phenylephrine, was not effective.

Advisory Committees are usually called when there is a “scientific, technical, or policy question” around a product or medication. The meetings are convened to review research, have an open discussion, and offer opinions on what the FDA should do. Advisory Committees are overwhelmingly made up of doctors, researchers, pharmacists, sometimes a patient representative, and always an industry and consumer representative. (Disclosure: I am the appointed Consumer representative on the FDA Drug Safety and Risk Management Committee).

In 2023, the patient representative on the advisory committee analyzing the efficacy of oral phenylephrine noted:

“I feel this drug, in this oral dose, should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”

After the 2023 meeting, the FDA published a statement explaining that they would consider withdrawing approval of oral phenylephrine but that it was safe to use in the meantime. So essentially, what the FDA said was, “this medication won’t do anything for your congestion, but probably won’t harm you, so you can continue using it.”

When this statement was released over a year ago, I asked the question: Why would anyone take—or prescribe—a drug that doesn’t work and can harm? (Because every drug can harm.) But that is precisely what the FDA has been allowing.

The good news? Things are beginning to change.

On November 7th, 2024, the FDA finally proposed to remove oral phenylephrine from the market. The process includes allowing time for public comment on the proposal and then FDA review of those comments. There is no specific timeline for removing oral phenylephrine—an ingredient that the FDA concedes likely does not work—from the shelves.

What’s the Difference Between Sudafed and Sudafed PE?

The similar names of Sudafed (with the active ingredient pseudoephedrine) and Sudafed PE (with the active ingredient phenylephrine) often creates confusion.

Pseudoephedrine, Sudafed’s primary ingredient, is an effective drug for congestion (although it does have its own side effects). However, it also has central nervous system (CNS) stimulant properties and can be misused for non-medical purposes in the same way that amphetamines are often misused. Additionally, pseudoephedrine is a precursor to the production of methamphetamine, which means it can be used to create illicit drugs in home labs. Because of this connection, you have to go up to a pharmacy counter—instead of picking it off a drug store shelf—and ask for Sudafed, and usually show an I.D

When the FDA moved Sudafed behind the pharmacy counter, a new type of OTC decongestant product was introduced: Sudafed PE, with phenylephrine as the prime ingredient. While phenylephrine sounds similar to pseudoephedrine, early studies around its effectiveness do not appear to have been peer-reviewed and may have been plagued with either methodologic problems or even possible fraud. Phenylephrine, of course, is the same ingredient the FDA Advisory Committee reviewed and voted unanimously on its ineffectiveness in 2023.

Do Any Phenylephrine Medications Work for Nasal Congestion?

Phenylephrine doesn’t work in an oral pill form because it breaks down in your body before reaching your nasal system, reducing its bioavailability (the portion of a drug that enters the bloodstream). However, when sprays or drops are used directly in the nose, phenylephrine does appear to help clear congestion.

Side Effects of Phenylephrine

It’s important to note that while the FDA mulls over the decision to pull oral phenylephrine from the market, the ineffective ingredient is still available for purchase and comes with its own side effects.

Three of its most common side effects—nervousness, dizziness and sleeplessness—are not likely to cause long-term harm, but they can certainly intrude on your day and make you feel even sicker than before taking the medicine. Many people can’t stay home in bed just because of congestion, and if you need to drive a car or take care of small children, dizziness, nervousness and exhaustion from sleeplessness can add up to a substantial safety issue.

Why the FDA Should Remove Phenylephrine From the Market

According to the Consumer Healthcare Products Association (CHPA), a trade group representing producers of non-prescription medications, more than half of all American households use phenylephrine either on its own or in a combination cold/flu remedy every year, with many of those households using it multiple times a year.

In my opinion, this is a waste of money and may even prolong recovery.

When you or someone you love takes a drug that doesn’t work, four things can happen:

You do not receive medicinal care for your illness
You may suffer from side effects with no possibility of benefit
Effective care may be delayed
You have wasted money

In the U.S., nearly every decongestant or cold/flu combination medicine available in the drugstore aisle contains phenylephrine. For your reference, here is a short list of the most common meds that include the ineffective oral ingredient:

Here is an abbreviated list of products that contain pseudoephedrine (an effective drug for clearing congestion). To get any of these products, you will have to go to the counter at the pharmacy:

FDA, please do your job and protect us all from ineffective and dangerous drugs.

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Article HTML

                    <!-- wp:paragraph -->
<p>In October 2023, I wrote about the Food and Drug Administration (FDA)’s <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/nonprescription-drugs-advisory-committee" target="_blank" rel="noreferrer noopener">Nonprescription Drugs Advisory Committee</a> and its unanimous vote that the primary ingredient in Sudafed PE and many other OTC cold medicines, oral phenylephrine, <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine" target="_blank" rel="noreferrer noopener">was not effective</a>.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><a href="https://www.fda.gov/patients/learn-about-fda-advisory-committees" target="_blank" rel="noreferrer noopener">Advisory Committees</a> are usually called when there is a “scientific, technical, or policy question” around a product or medication. The meetings are convened to review research, have an open discussion, and offer opinions on what the FDA should do. Advisory Committees are overwhelmingly made up of doctors, researchers, pharmacists, sometimes a patient representative, and always an industry and consumer representative. (Disclosure: I am the appointed Consumer representative on the <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/drug-safety-and-risk-management-advisory-committee" target="_blank" rel="noreferrer noopener">FDA Drug Safety and Risk Management Committee</a>).</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>In 2023, the patient representative on the advisory committee analyzing the efficacy of oral phenylephrine <a href="https://www.statnews.com/2023/09/12/popular-nasal-decongestant-doesnt-relieve-congestion-sudafed-allegra/" target="_blank" rel="noreferrer noopener">noted</a>:</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>“I feel this drug, in this oral dose, should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>After the 2023 meeting, the FDA <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine" target="_blank" rel="noreferrer noopener">published</a> a statement explaining that they would consider withdrawing approval of oral phenylephrine but that it was safe to use in the meantime. So essentially, what the FDA said was, “this medication won’t do anything for your congestion, but probably won’t harm you, so you can continue using it.”</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>When this statement was released over a year ago, I asked the question: Why would anyone take—or prescribe—a drug that doesn’t work and can harm? (Because every drug can harm.) But that is precisely what the FDA has been allowing.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>The good news? Things are beginning to change.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>On November 7th, 2024, the FDA finally <a href="https://www.fda.gov/drugs/understanding-over-counter-medicines/key-information-about-nonprescription-over-counter-otc-oral-phenylephrine" target="_blank" rel="noreferrer noopener">proposed to remove</a> oral phenylephrine from the market. The process includes allowing time for <a href="https://www.federalregister.gov/documents/2024/11/08/2024-25910/amending-over-the-counter-monograph-m012-cold-cough-allergy-bronchodilator-and-antiasthmatic-drug" target="_blank" rel="noreferrer noopener">public comment</a> on the proposal and then FDA review of those comments. There is no specific timeline for removing oral phenylephrine—an ingredient that the FDA concedes likely does not work—from the shelves.</p>
<!-- /wp:paragraph -->

<!-- wp:heading -->
<h2 class="wp-block-heading">What’s the Difference Between Sudafed and Sudafed PE?</h2>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p>The similar names of Sudafed (with the active ingredient pseudoephedrine) and Sudafed PE (with the active ingredient phenylephrine) often creates confusion.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>Pseudoephedrine, Sudafed’s primary ingredient, is an <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC8152226/" target="_blank" rel="noreferrer noopener">effective drug for congestion</a> (although it does have its own <a href="https://www.health.harvard.edu/heart-health/dont-let-decongestants-squeeze-your-heart" target="_blank" rel="noreferrer noopener">side effects</a>). However, it also has central nervous system (CNS) stimulant properties and can be misused for non-medical purposes in the same way that amphetamines are often misused. Additionally, pseudoephedrine is a precursor to the production of methamphetamine, which means it can be used to create illicit drugs in home labs. Because of this connection, you have to go up to a pharmacy counter—instead of picking it off a drug store shelf—and <a href="https://www.fda.gov/drugs/information-drug-class/legal-requirements-sale-and-purchase-drug-products-containing-pseudoephedrine-ephedrine-and" target="_blank" rel="noreferrer noopener">ask for Sudafed</a>, and usually show an I.D</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>When the FDA moved Sudafed behind the pharmacy counter, a new type of OTC decongestant product was introduced: Sudafed PE, with phenylephrine as the prime ingredient. While phenylephrine sounds similar to pseudoephedrine, early studies around its effectiveness <a href="https://www.pharmacist.com/CEO-Blog/phenylephrine-the-story-of-an-ineffective-nasal-decongestant#:~:text=According%20to%20Hatton%2C%20the%20systematic,shown%20it%20to%20be%20ineffective.%E2%80%9D" target="_blank" rel="noreferrer noopener">do not appear to have been peer-reviewed</a> and may have been plagued with either methodologic problems or even possible fraud. Phenylephrine, of course, is the same ingredient the FDA Advisory Committee reviewed and voted unanimously on its ineffectiveness in 2023.</p>
<!-- /wp:paragraph -->

<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Do Any Phenylephrine Medications Work for Nasal Congestion?</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p>Phenylephrine doesn’t work in an oral pill form because it breaks down in your body before reaching your nasal system, reducing its bioavailability (the portion of a drug that enters the bloodstream). However, when sprays or drops are used directly in the nose, phenylephrine does appear <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC10730950/#:~:text=Safety%20assessments%20showed%20no%20life,alleviating%20nasal%20congestion%20in%20adults." target="_blank" rel="noreferrer noopener">to help clear congestion</a>.</p>
<!-- /wp:paragraph -->

<!-- wp:heading -->
<h2 class="wp-block-heading">Side Effects of Phenylephrine</h2>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p>It’s important to note that while the FDA mulls over the decision to pull oral phenylephrine from the market, the ineffective ingredient is still available for purchase and comes with its own side effects.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>Three of its most <a href="https://medlineplus.gov/druginfo/meds/a606008.html#side-effects" target="_blank" rel="noreferrer noopener">common side effects</a>—nervousness, dizziness and sleeplessness—are not likely to cause long-term harm, but they can certainly intrude on your day and make you feel even sicker than before taking the medicine. Many people can’t stay home in bed just because of congestion, and if you need to drive a car or take care of small children, dizziness, nervousness and exhaustion from sleeplessness can add up to a substantial safety issue.</p>
<!-- /wp:paragraph -->

<!-- wp:heading -->
<h2 class="wp-block-heading">Why the FDA Should Remove Phenylephrine From the Market</h2>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p>According to the Consumer Healthcare Products Association (CHPA), a trade group representing producers of non-prescription medications, more than <a href="https://www.chpa.org/news/2023/09/statement-sept-11-12-2023-meeting-fda-ndac-evaluate-efficacy-oral-pe" target="_blank" rel="noreferrer noopener">half of all American households</a> use phenylephrine either on its own or in a combination cold/flu remedy every year, with many of those households using it multiple times a year.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>In my opinion, this is a waste of money and may even prolong recovery.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>When you or someone you love takes a drug that doesn’t work, four things can happen:</p>
<!-- /wp:paragraph -->

<!-- wp:list -->
<ul class="wp-block-list"><!-- wp:list-item -->
<li>You do not receive medicinal care for your illness</li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li>You may suffer from side effects with no possibility of benefit</li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li>Effective care may be delayed</li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li>You have wasted money</li>
<!-- /wp:list-item --></ul>
<!-- /wp:list -->

<!-- wp:paragraph -->
<p>In the U.S., nearly every decongestant or cold/flu combination medicine available in the drugstore aisle contains phenylephrine. For your reference, here is a short list of the most common meds that include the ineffective oral ingredient:</p>
<!-- /wp:paragraph -->

<!-- wp:list -->
<ul class="wp-block-list"><!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a38fdfb8-db89-487f-9b68-aa9152b91f5f" target="_blank" rel="noreferrer noopener">Sudafed PE Sinus Congestion</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d" target="_blank" rel="noreferrer noopener">Children’s Sudafed PE Nasal Decongestant</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=685b51d3-cc25-47b2-ac8a-368924f43137" target="_blank" rel="noreferrer noopener">Benadryl Allergy Plus Congestion</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b23005c2-2560-4cae-ab94-6a419c44ccc3" target="_blank" rel="noreferrer noopener">PediaCare Children’s Multi-Symptom Cold</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10ae1774-6e64-4b75-941b-8facd63a66e8" target="_blank" rel="noreferrer noopener">Vicks DayQuil Cold and Flu</a></li>
<!-- /wp:list-item --></ul>
<!-- /wp:list -->

<!-- wp:paragraph -->
<p>Here is an <a href="https://www.mayoclinic.org/drugs-supplements/pseudoephedrine-oral-route/description/drg-20067942" target="_blank" rel="noreferrer noopener">abbreviated list of products that contain pseudoephedrine</a> (an effective drug for clearing congestion). To get any of these products, you will have to go to the counter at the pharmacy:</p>
<!-- /wp:paragraph -->

<!-- wp:list -->
<ul class="wp-block-list"><!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d600b5d5-7d95-4ad6-a95b-6d73502743d7" target="_blank" rel="noreferrer noopener">Sudafed Sinus Congestion</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7125705-01ff-4418-8c53-9209c2bbb484" target="_blank" rel="noreferrer noopener">Claritin-D</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c9d819d-0f3f-4c76-9770-cf004b10299a&type=display" target="_blank" rel="noreferrer noopener">Zyrtec-D</a></li>
<!-- /wp:list-item -->

<!-- wp:list-item -->
<li><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0da9ed22-bfb4-d61b-110b-0c7760332a98" target="_blank" rel="noreferrer noopener">Advil Cold and Sinus</a></li>
<!-- /wp:list-item --></ul>
<!-- /wp:list -->

<!-- wp:paragraph -->
<p>FDA, please do your job and protect us all from ineffective and dangerous drugs.</p>
<!-- /wp:paragraph -->

Opinion: FDA Proposes Removing Sudafed PE and Cold Meds

What’s the Difference Between Sudafed and Sudafed PE?

Do Any Phenylephrine Medications Work for Nasal Congestion?

Side Effects of Phenylephrine