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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. • Studies by Merck and Johnson & Johnson indicated no significant difference between phenylephrine and placebos in relieving congestion. • The FDA noted that phenylephrine appears more effective when applied directly to the nose, as in sprays or drops, which are not under review.

The U.S. Food and Drug Administration (FDA) has announced a proposal to remove oral phenylephrine from over-the-counter (OTC) medications. This decision is based on concerns that the drug, commonly found in popular cough and cold products, is not effective when taken orally.

History and Usage of Phenylephrine

Phenylephrine has been used as a nasal decongestant since its approval by federal health regulators in 1976. By 2006, it became a primary ingredient in many OTC medicines, replacing pseudoephedrine, which was moved behind pharmacy counters due to its potential use in methamphetamine production. Products containing phenylephrine are available as single-ingredient medications or in combination with other active ingredients like acetaminophen or dextromethorphan.

Efficacy Concerns

The effectiveness of oral phenylephrine has been under scrutiny for several years. Recent studies by pharmaceutical companies such as Merck and Johnson & Johnson have indicated that phenylephrine is no more effective than a placebo in relieving nasal congestion. These findings led CVS Health to remove oral decongestants containing phenylephrine as the sole active ingredient from its shelves last year.
Dr. Dipak Chandy of Westchester Medical Center characterized oral phenylephrine as "a completely pointless drug" when CVS removed the products, noting it provides no benefit to consumers when taken orally.
The FDA has stated that the presence of oral phenylephrine does not affect the efficacy of other active ingredients in these combination medications designed to treat other symptoms.

Alternative Administration

The FDA has indicated that phenylephrine appears to be effective when administered directly into the nose through sprays or drops. These products are not part of the current proposal for removal.

Industry Response

The Consumer Healthcare Products Association has expressed disappointment with the FDA’s proposal, emphasizing the importance of access to safe and effective OTC medicines for consumers.
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Reference News

[1]
FDA wants to pull decongestant found in many cold, allergy medicines | FOX 26 Houston
fox26houston.com · Nov 10, 2024

The FDA proposes removing oral phenylephrine, a decongestant in many OTC cold and flu meds, due to concerns over its eff...

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