Nasal Decongestant Effectiveness Questioned by FDA Advisers

by Ethan Kim
Nasal Decongestant Efficacy

A prominent nasal decongestant widely used by millions of Americans to alleviate stuffy noses may not be as effective as previously thought. Government experts, convened by the Food and Drug Administration (FDA), have unanimously voted against the effectiveness of the primary drug found in popular over-the-counter decongestants such as Sudafed, Allegra, and Dayquil.

The drug in question is phenylephrine, which has become the main ingredient in over-the-counter decongestants since medicines containing pseudoephedrine were moved behind pharmacy counters due to concerns about its potential illegal use in the production of methamphetamine.

Recent studies have cast doubt on the efficacy of phenylephrine in relieving congestion. Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, stated, “Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine.”

If the FDA chooses to follow the panel’s recommendations, major pharmaceutical companies like Johnson & Johnson and Bayer may be required to remove oral medications containing phenylephrine from store shelves. This decision would likely prompt consumers to turn to either behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops.

The FDA would need to collaborate with drugstores, pharmacists, and other healthcare providers to educate consumers about alternative congestion relief options should this scenario unfold.

Dr. Paul Pisaric of Archwell Health in Oklahoma raised concerns about the safety of phenylephrine, particularly at higher doses, which can potentially elevate blood pressure to dangerous levels. This safety issue further complicates the drug’s continued use.

The impetus for the FDA review came from researchers at the University of Florida who petitioned for the removal of most phenylephrine products based on recent studies showing that they did not outperform placebo pills in patients with cold and allergy congestion. Similar doubts about the drug’s effectiveness were raised in 2007, but at that time, the FDA allowed the products to remain on the market pending further research.

This time, the FDA panel unanimously agreed that current evidence does not support the benefit of phenylephrine as a decongestant. They concurred with the conclusions of an FDA scientific review, which found significant flaws in studies from the 1960s and 1970s that originally supported phenylephrine’s approval.

Three more recent, rigorously conducted studies, dating from 2016, showed no significant difference between phenylephrine medications and placebos for relieving congestion. These studies, conducted by Merck and Johnson & Johnson, involved hundreds of patients.

The Consumer Healthcare Products Association, a trade group representing nonprescription drugmakers, argued that the new studies had limitations and advocated for continued consumer access to phenylephrine.

Phenylephrine’s long history on the market, predating the FDA’s drug effectiveness regulations, has contributed to its continued use. However, the FDA’s latest assessment reveals that the drug is metabolized too rapidly when taken orally, leaving only trace amounts to relieve nasal congestion. In contrast, phenylephrine appears to be more effective when applied directly to the nose in the form of sprays or drops, which are not currently under review.

While the FDA panel’s decision is not binding, it may pave the way for the FDA to remove phenylephrine from its list of effective over-the-counter decongestants. Such a move would eliminate unnecessary costs and delays associated with using a drug that offers no discernible benefit.

The FDA’s nasal decongestant drug list, or monograph, has not been updated since 1995. However, a 2020 law passed by Congress streamlines the process for updating monographs, potentially allowing the FDA to publish new standards for nonprescription ingredients more swiftly.

Frequently Asked Questions (FAQs) about Nasal Decongestant Efficacy

What is phenylephrine, and why is it being questioned by FDA advisers?

Phenylephrine is a common ingredient in over-the-counter nasal decongestants. FDA advisers have raised concerns about its effectiveness in relieving congestion based on recent studies.

What did the FDA advisers conclude about phenylephrine’s effectiveness?

The FDA panel unanimously voted against the effectiveness of phenylephrine in relieving congestion, citing modern studies that failed to show any improvement.

How might this impact the over-the-counter decongestant market?

If the FDA follows the panel’s recommendations, major pharmaceutical companies may be required to remove phenylephrine-based oral medications from store shelves. Consumers might need to turn to alternative products or behind-the-counter options.

What safety concerns were raised about phenylephrine?

There were concerns that phenylephrine, particularly at higher doses, could potentially raise blood pressure to dangerous levels, which further complicates its use as a decongestant.

Why did the FDA decide to reevaluate phenylephrine’s effectiveness?

The FDA’s review of phenylephrine’s effectiveness was prompted by recent studies that showed it did not outperform placebo pills in relieving congestion. Similar doubts had been raised in 2007, but the products remained on the market pending further research.

What alternatives are available for congestion relief?

Consumers may need to consider behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops as potential alternatives for congestion relief.

Is there a timeline for potential changes in the status of phenylephrine products?

The FDA panel’s decision is not binding, but it could lead to the removal of phenylephrine from the list of effective over-the-counter decongestants, eliminating unnecessary costs and delays associated with its use. The process for such changes typically takes years or decades, but recent legislation may expedite the process.

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HealthNut1 September 13, 2023 - 2:14 pm

The FDA advisers, they all agree, phenylephrine not good for stuffy nose

Reader123 September 13, 2023 - 2:15 pm

hey, so fda they say this nasal thing dont work, wow

PharmaPro September 13, 2023 - 7:23 pm

FDA review shows phenylephrine might not help congestion, big problem for OTC meds


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