FDA Panel: Widely Used Oral Decongestant Phenylephrine Ineffective, Waste of Money

An FDA advisory committee unanimously agreed that the oral decongestant phenylephrine, found in many OTC allergy/cold medicines, is ineffective in tablet form.
The ingredient is considered safe, but studies show it is not effective when taken orally due to being absorbed and metabolized before reaching the bloodstream.
The FDA approved phenylephrine for OTC use in the 1970s, and it became more common after 2005 when pseudoephedrine access was restricted.
The advisory committee concluded that products containing ineffective phenylephrine tablets are a waste of money, when other oral and nasal decongestants are available.
If the FDA decides to reclassify phenylephrine based on this advice, manufacturers would have opportunity to comment before phenylephrine products might be removed.

cnn.com

Relevant topic timeline:

9/13/2023

FDA Panel: Phenylephrine Oral Decongestants Like Sudafed No Better Than Placebo, Recommends Removing From Store Shelves

The leading decongestant phenylephrine, found in popular medications like Sudafed, has been deemed no more effective than a placebo by government experts, prompting possible removal from store shelves.

9/13/2023

FDA Questions Effectiveness of Common Cold Medicine Ingredient Phenylephrine

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9/14/2023

Major Companies Sued for False Marketing of Ineffective Phenylephrine in Cold Medicines

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9/27/2023

Medical experts are recommending alternatives to oral decongestants, such as corticosteroid nasal sprays, antihistamines, steam, and rest, after the FDA voted against the effectiveness of phenylephrine in relieving nasal congestion.

9/29/2023

FDA Panel Finds Common Decongestant Ingredient Ineffective, But Phenylephrine Products Remain on Market for Now

Over 200 over-the-counter decongestants containing phenylephrine, a key ingredient just revealed to be ineffective, are still on pharmacy shelves despite evidence dating back to 2007 showing that it doesn't work.