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FDA Panel Finds Common Oral Decongestant Ineffective, Potentially Leading to Removal of Medications From Shelves

  • An FDA advisory panel unanimously found that the oral decongestant phenylephrine, used in many over-the-counter cold medications, is no more effective than a placebo.
  • The FDA will decide whether to remove oral phenylephrine products from the market, which could force drugmakers to reformulate popular cold and allergy medicines.
  • Phenylephrine replaced pseudoephedrine in many medications after the latter was restricted due to risks of illegal use.
  • Recent clinical trials and the FDA's own analysis found no evidence that oral phenylephrine relieves nasal congestion.
  • Nasal sprays containing phenylephrine were not evaluated and are considered effective alternatives.
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