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FDA Panel Finds Popular Decongestant Ingredient No Better Than Placebo, Questioning $1.7B Industry

  • Phenylephrine, the active ingredient in many popular decongestants, is no more effective than a placebo, according to an FDA panel.

  • The panel cited issues with how phenylephrine is absorbed, with less than 1% reaching the body compared to earlier estimates of 38%.

  • Products containing phenylephrine had over $1.7 billion in sales in 2022, including Sudafed PE, Mucinex, and store brands.

  • The FDA panel will determine if phenylephrine's GRASE status should be revoked, which could remove products from shelves.

  • Patients may need guidance on using pseudoephedrine products or alternative treatments like nasal sprays.

webmd.com
Relevant topic timeline:
FDA Advisors Call for Removal of Ineffective Decongestant Phenylephrine from Cold Medicines
An advisory panel to the FDA unanimously declared that the main ingredient found in popular cold and allergy medications, phenylephrine, does not effectively relieve nasal congestion, potentially leading to the removal of these products from store shelves.