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Phenylephrine was approved in the 1960s-70s based on small, outdated studies; the FDA now says it does not meet modern effectiveness standards.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

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Phenylephrine was approved in the 1960s-70s based on small, outdated studies; the FDA now says it does not meet modern effectiveness standards.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