The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency’s list of ingredients for over-the-counter (OTC) use.

The FDA’s clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.

If the FDA concurs with the panel’s view, it will first issue a proposed order removing phenylephrine from the list of ingredients that are allowed in OTC drugs, and seek public comment on it.

After considering the comments, if the FDA continues to conclude phenylephrine is not effective, the agency would issue a final order on it and work with manufacturers to reformulate products to effectively treat symptoms of cold or allergies.

  • @[email protected]
    link
    fedilink
    English
    661 year ago

    To be clear, they’re trying to get rid of it because oral phenylephrine doesn’t work. It’s completely ineffective at being a decongestant.

      • @[email protected]
        link
        fedilink
        41 year ago

        Phenylephrine is also linked to birth defects in pregnant women, while pseudoephedrine is not. My wife’s OB recommended sudafed when she had a cold. The pharmacy tech pointed her to the aisle with SudafedPE when she asked for Sudafed. So it’s ineffective and dangerous.

    • @[email protected]
      link
      fedilink
      14
      edit-2
      1 year ago

      I always (anecdotally) knew that this was just a cash grab by pharma companies to have “something” available without having to go to the pharmacy counter. It never worked for me, so I moved to other remedies if I ran out of psuedoepbedrine - steam, menthol, lemon/ginger/honey concoctions. All more effective for me.

      • @just_change_it
        link
        131 year ago

        I just go to the pharmacy counter because i’m an adult. No replacement for pseudo out there that i’ve seen in folk remedies. Do like honey and limon water for throat stuff though.

        • Meldroc
          link
          English
          71 year ago

          Yep, I’ve made my trips to go on the Federal List of People with Head Colds.