FDA proposes to remove ingredient in medications

Reporter: Amy Oshier Writer: Kendell Gordon
Published: Updated:
CANCER
FILE – A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. According to research published Sunday, April 7, 2024, in the Journal of the American Medical Association, most cancer drugs granted accelerated approval by the FDA, meant to give patients early access to promising drugs, do not demonstrate such benefits within five years. (AP Photo/Manuel Balce Ceneta, File)

Changes could be coming to some common over-the-counter medications.

The Food & Drug Administration proposes removing one ingredient after new data shows it is less effective than listed. 

Oral phenylephrine is widely used as a nasal decongestant in products like Sudafed PE, Vicks Dayquil, and Mucinex Sinus-Max.

The drug’s safety isn’t a concern, but the FDA says it’s proposing removing it because it is not effective.

Its effectiveness has been debated for years.

If the FDA moves forward with banning the ingredient, it will allow manufacturers time to either reformulate or remove drug products containing the drug from the market.  

CVS started proactively removing some over-the-counter allergy and cold medicines from its shelves last month.

The FDA wants to hear about your experiences with the drug. To share your thoughts go to OTC Monographs@FDA.

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