A Food and Drug Administration (FDA) advisory panel recently reached a decision that could have significant implications for the over-the-counter (OTC) pharmaceutical market: phenylephrine, a common ingredient in many cold and allergy medications, is ineffective at relieving nasal congestion.
This declaration targets oral formulations of phenylephrine and is expected to disrupt the market for over-the-counter cold and allergy remedies, where consumers prefer tablets to nasal mists.
FDA Reviews Future of Phenylephrine-Containing Cold Meds
Popular medications such as Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion contain phenylephrine.
According to FDA data, it generated nearly $1.8 billion in sales in the United States in 2022 alone.
The substance is believed to relieve congestion by minimizing the dilation of blood vessels in the nasal passages.
However, the FDA presented compelling evidence that when phenylephrine is consumed orally, only a minuscule quantity of the drug reaches the nasal passages, rendering it ineffective.
Susan Blalock, a retired professor from the UNC Eshelman School of Pharmacy and an advisory committee member, stated, “The evidence is quite convincing that this medication is ineffective. I do not believe additional evidence is required to substantiate this conclusion.”
The FDA must decide whether to revoke phenylephrine’s OTC status as “generally recognized as safe and effective.”
Frequently granted to older medications, this designation allows drug manufacturers to include a constituent in over-the-counter products without filing an FDA application.
If the appointment is revoked, manufacturers may be required to remove phenylephrine-containing products from shelves or devise new formulations.
Unknown is the timeline for the FDA’s decision.
Jennifer Schwartzott, a patient representative from New York, expressed her concerns and emphasized the need for symptom-treating medications.
She stated, “This drug and oral dose should have been removed from the market long ago.”
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A Turning Point for OTC Cold Meds
In the early 2000s, phenylephrine acquired popularity as a substitute for pseudoephedrine, which was placed behind pharmacy counters in 2006 out of concern for its misuse in methamphetamine production.
During a two-day meeting, FDA scientists presented the findings of five studies on the efficacy of oral phenylephrine conducted over the past two decades.
These studies concluded that the decongestant was equivalent to a placebo in effectiveness.
In addition, the FDA examined the initial findings supporting its over-the-counter use and discovered inconsistencies and issues with study design and data integrity.
Dr. PETER STARKE, the FDA official in charge of the phenylephrine evaluation, stated, “We believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant.”
In addition to its ineffectiveness, phenylephrine can cause migraines, insomnia, and anxiety. It can increase blood pressure at greater concentrations.
The advisory panel’s decision does not call into doubt the efficacy of phenylephrine nasal spray, which is still considered to provide temporary congestion relief.
Consumer Healthcare Products Association representatives, who represent OTC drug manufacturers, did not present any new evidence to refute the FDA’s claims regarding phenylephrine’s inefficacy.
They argued that removing oral phenylephrine from the over-the-counter (OTC) market would harm consumers.
They cited a survey demonstrating that 1 in 2 U.S. households used an oral decongestant in the past year, with a 3-to-1 preference for oral decongestants over nasal aerosols.
However, members of the advisory committee disagreed with this viewpoint. Dr. Maryann Amirshahi, a professor of emergency medicine at Georgetown University School of Medicine, noted that pseudoephedrine, available behind pharmacy counters, is an effective alternative ensuring its responsible use.
The FDA’s decision regarding phenylephrine highlights the significance of rigorous evaluation and consumer safety in the market for over-the-counter (OTC) pharmaceuticals, potentially reshaping the industry to meet the needs of patients better.
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