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.

    • Hyperreality
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      136 months ago

      Fucking war on drugs.

      As if someone buying a box of pseudoephedrine is going to become Walter White, when organised crime makes meth by the tonne.

      It’s really hard to buy pseudoephedrine in many countries now, meanwhile organised crime is making more meth than ever.

      • Zeppo
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        56 months ago

        It’s outdated at this point since the era of homemade meth has come and gone, due to the excessive supply of higher quality from Mexican cartels.

    • @GlitterInfection@lemmy.world
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      96 months ago

      Well, yes, that is an important distinction from the headline. The behind the counter vs over the counter distinction is minor but also important as well.

    • @silentknyght@lemmy.world
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      26 months ago

      I think that was the point of the question: there is only one real option, pseudoephedrine.

      Are there decongestant nasal sprays or something? I’ve been taking phenylephrine because I believed it worked–even though it was a placebo --and never looked at other options. I don’t tolerate pseudoephedrine well.

      • @gamermanh@lemmy.dbzer0.com
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        26 months ago

        Phenylephrine somewhat works as a nasal decongestant

        There are other comments with some science links and I can confirm through experience that comparing PE PILLS to PE spray the spray actually does something

        Not nearly the same effect as pseudoephedrine

        There’s also Fluticasone (Flonase) but I wouldn’t recommend that unless you’re desperate or rich (in my area a small bottle of PE spray costs like 5 bucks, the base Flonase that has about half the drugs in it is almost 20)

      • @theUnlikely@sopuli.xyz
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        16 months ago

        I swear by nasal sprays that contain xylometazoline. If I get a cold, it’s the only thing that lets me actually breathe so I can fall asleep.