A loophole in FDA processes means older drugs like the ones in oral decongestants weren’t properly tested. Here’s how we learned the most popular one doesn’t work

In 2005, federal law compelled retailers nationwide to move pseudoephedrine, sold as Sudafed, from over-the-counter (OTC) to behind it, so as to combat its use in making illicit methamphetamine. This move changed the formulas of cough and cold medicines in the U.S… It also led me and my colleague Leslie Hendeles to prove that pseudoephedrine’s replacement, oral phenylephrine, was ineffective as a decongestant.

We petitioned the Food and Drug Administration (FDA) twice, yet it took the agency more than a decade and a half to act on our findings.

In September, an agency advisory panel finally agreed with our conclusion that this compound did little to quell congestion and recommended that products containing it be pulled from shelves. If FDA acts on this recommendation, oral phenylephrine could be the first OTC drug approved under the agency’s “monograph” process to be discontinued. But in the meantime, millions of people have been trusting the FDA’s OTC regulatory process to ensure that medications work, but instead have been wasting money for nearly two decades on ones that don’t.

  • Pratai@lemmy.ca
    link
    fedilink
    English
    arrow-up
    3
    arrow-down
    2
    ·
    edit-2
    11 months ago

    I read the article, asshole. Claritin-D has pseudoephedrine in it. Which is what I asked what I asked.

    YOU are the worst kind of lemmy user. You’re an arrogant blowhard that has to say shit when they could have just scrolled past and ignored what you didn’t understand.

    Take your likes and delete your embarrassing response.

    • CrayonRosary@lemmy.world
      link
      fedilink
      English
      arrow-up
      1
      arrow-down
      1
      ·
      edit-2
      11 months ago

      Claritin-D has pseudoephedrine

      You clearly didn’t read the article which says nothing about pseudoephedrine not working. If you had, you wouldn’t have had to ask. Can you not tell the difference between the words pseudoephedrine and phenylephrine?

      Even if we give you the benefit of the doubt, and you were asking a sincere question after having read the article, it was a really poor one. You could have mentioned what your confusion was, but you were to lazy to do even that.

      what you didn’t understand.

      Funny.

      Take your likes

      Take my what now?

      • Pratai@lemmy.ca
        link
        fedilink
        English
        arrow-up
        1
        arrow-down
        1
        ·
        11 months ago

        It took 5 seconds on google:

        Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate in an extended-release core. Claritin-D 24 hour extended release tablets are white to off-white oval, biconvex, coated tablets branded in black with “CLARITIN-D 24 HOUR”.

        Stop being stupid.

        • CrayonRosary@lemmy.world
          link
          fedilink
          English
          arrow-up
          2
          ·
          edit-2
          11 months ago

          Did you still not read the article? Pseudoephedrine WORKS! Oral Phenylephrine DOES NOT! Claritin does NOT contain Phenylephrine. The article says nothing about pseudoephedrine not working, and yet you still don’t get it!

          No one ever said anywhere that Claritin-D doesn’t contain pseudoephedrine. No one! No one ever said pseudoephedrine doesn’t work. Who are you arguing against? Why are you so dense?

          Article:

          Phenylephrine doesn’t work.

          You:

          I swear Claritin works! I’m so confused!

          Me:

          Claritin isn’t phenylephrine, read the label.

          You:

          Nuh uh! Google says it contains pseudoephedrine!!

          Me: 🤦‍♂️