MedPath

FDA Proposes Removing Oral Phenylephrine from OTC Nasal Decongestants

• The FDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products for temporary nasal congestion relief. • This decision follows an FDA review that concluded oral phenylephrine is ineffective in relieving nasal congestion at recommended doses. • The proposal does not affect phenylephrine nasal sprays, which remain approved; the FDA will accept public comments before issuing a final order. • Consumers are advised that alternative safe and effective treatments are available for nasal congestion due to allergies or the common cold.

The U.S. Food and Drug Administration (FDA) has announced a proposal to remove oral phenylephrine from the list of active ingredients in over-the-counter (OTC) monograph drug products intended for temporary relief of nasal congestion. This action follows an agency review of existing data, which led to the conclusion that oral phenylephrine has not been shown to be effective as a nasal decongestant.

Ineffective Nasal Decongestant

According to Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), the FDA's role is to ensure that drugs are both safe and effective. The proposal to remove oral phenylephrine is based on a review of available data and consistent with the advice of the advisory committee.
Oral phenylephrine is a commonly used ingredient found in many OTC nasal decongestant medications, either as a single active ingredient or in combination with other drugs like acetaminophen or dextromethorphan. The FDA noted that the presence of phenylephrine in multi-ingredient formulations does not affect the function of the other active ingredients in addressing their intended symptoms.

Historical Data vs. Recent Evidence

While older research from around 30 years ago supported the use of oral phenylephrine for nasal decongestion, more recent clinical evidence suggests otherwise. The FDA’s Nonprescription Drug Advisory Committee convened to discuss the ingredient's status under the “Generally Recognized as Safe and Effective” (GRASE) designation for use in nasal decongestants. The committee unanimously agreed that current research does not support the effectiveness of oral phenylephrine at the recommended doses in OTC products.

Nasal Sprays Not Affected

The FDA clarified that this proposal does not impact phenylephrine nasal sprays, which remain approved for nasal congestion treatment.

Public Comment and Next Steps

The FDA is now inviting public comments on the proposed order. Following a review of the feedback, the agency will issue its final order regarding phenylephrine’s use in the OTC monograph. If the order is finalized, manufacturers will be given time to either reformulate products containing oral phenylephrine or withdraw them from the market.
Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, stated that consumers should know that a range of safe and effective drugs and other treatments are available to temporarily relieve congestion symptoms due to allergies or a common cold. Consumers are also encouraged to consult their doctor or pharmacist about ways to treat these symptoms.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Moves to Remove Oral Phenylephrine as Decongestant Due to Ineffectiveness

The FDA is moving to phase out oral phenylephrine, a common decongestant in over-the-counter cold medicines, after determining it is no more effective than a placebo.
This decision follows expert reviews of studies dating back to the 1960s, which revealed flaws and questionable data regarding phenylephrine's efficacy in oral form.

FDA Proposes Removal of Oral Phenylephrine from OTC Nasal Decongestants

The FDA is proposing to remove oral phenylephrine from over-the-counter nasal decongestants due to its ineffectiveness.
This decision follows a comprehensive review of clinical data and a unanimous recommendation from the Nonprescription Drug Advisory Committee.

FDA Proposes Ban on Oral Phenylephrine in OTC Cold Medications Due to Ineffectiveness

The FDA is proposing to remove oral phenylephrine, a common decongestant, from over-the-counter medications due to its lack of proven effectiveness.
Phenylephrine has been used since 1976 and became more prevalent after pseudoephedrine was moved behind pharmacy counters.

FDA Proposes Ban on Oral Phenylephrine Due to Ineffectiveness as Decongestant

The FDA is proposing to remove oral phenylephrine from over-the-counter cold medications due to its ineffectiveness as a nasal decongestant.
The decision follows a review of scientific data, including older determinations and recent research, indicating a lack of efficacy.

FDA Weighs Removal of Oral Phenylephrine; Approves Drugs for CML, Gastric Cancer, and UTIs

The FDA is considering removing oral phenylephrine from its OTC Monograph due to a lack of efficacy as a nasal decongestant, potentially impacting numerous cold and allergy products.
Novartis' Scemblix expands its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML).

FDA Proposes Ban on Oral Phenylephrine for Ineffective Nasal Decongestion Relief

The FDA is proposing to ban oral phenylephrine, a common ingredient in OTC cold medications, due to evidence of its ineffectiveness as a nasal decongestant.
The proposal follows an FDA advisory committee's conclusion that oral phenylephrine does not work, with the public comment period open until May 7, 2025.

FDA Proposes Ban on Oral Phenylephrine for Cold Relief Due to Ineffectiveness

The FDA is moving to remove oral phenylephrine from the list of approved over-the-counter ingredients due to its lack of efficacy as a nasal decongestant.
Scientific reviews indicate that less than 1% of orally administered phenylephrine is absorbed into the bloodstream, rendering it ineffective.

FDA Proposes Removal of Oral Phenylephrine as Ineffective Nasal Decongestant

The FDA is proposing to remove oral phenylephrine from over-the-counter (OTC) cold medications, deeming it ineffective as a nasal decongestant.
This decision follows a review of available data, including historical data and recent studies, which showed phenylephrine was no more effective than a placebo.

FDA Proposes Removal of Oral Phenylephrine as Ineffective Decongestant

The FDA has proposed removing oral phenylephrine from the list of approved over-the-counter decongestants due to its lack of efficacy in relieving nasal congestion.
This decision follows a review of available data and advice from an advisory committee, which concluded that oral phenylephrine is not effective as a nasal decongestant.

FDA Proposes Ban on Oral Phenylephrine in Over-the-Counter Decongestants

The FDA is seeking to ban oral phenylephrine in OTC nasal decongestants due to research indicating its ineffectiveness as a pill or syrup.
The proposal follows a review of data, including a September 2023 advisory committee conclusion, questioning phenylephrine's efficacy as a decongestant.

Reference News

[1]
FDA Suggests Removing Oral Phenylephrine as OTC Monograph Nasal Decongestant Ingredient
hcplive.com · Nov 7, 2024

The FDA proposed removing oral phenylephrine from OTC nasal congestion relief products due to lack of effectiveness, bas...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy