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

  • The FDA expert panel unanimously voted that phenylephrine, the main ingredient in many popular decongestants like Sudafed, is no more effective than a placebo for relieving nasal congestion.

  • The panel recommended that the FDA remove oral phenylephrine products from store shelves, which would force consumers to use pseudoephedrine products behind the pharmacy counter or phenylephrine nasal sprays/drops.

  • The panel reviewed new studies from 2016-2022 finding no benefit of phenylephrine pills over placebos for congestion relief.

  • Phenylephrine was approved in the 1960s-70s based on small, outdated studies; the FDA now says it does not meet modern effectiveness standards.

  • If the FDA follows the recommendation, it would update its over-the-counter drug monograph for the first time since 1995 to remove ineffective phenylephrine oral decongestants.

npr.org
Relevant topic timeline:
FDA Considers Pulling Ineffective Oral Phenylephrine from Over-the-Counter Medicines
The Food and Drug Administration (FDA) is considering whether to remove oral phenylephrine, a common ingredient in over-the-counter cold and cough medicines, from the market as a nasal decongestant due to research suggesting it is ineffective in relieving nasal congestion when taken orally.
FDA: Popular Oral Decongestant Ineffective, Recommends Alternative Congestion Relievers
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.