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posted by cmn32480 on Tuesday October 27 2015, @02:24PM   Printer-friendly
from the if-it-doesn't-work-why-is-it-popular dept.

Back before methamphetamine cooks started buying up non-prescription decongestants to brew crank, all of us were able to buy effective decongestants right off the store shelf without a problem. Now David DiSalvo writes at Forbes that to fill the store-shelf void, drug companies substituted the already-FDA approved ingredient phenylephrine for pseudoephedrine but the oral decongestant phenylephrine simply doesn't work at the FDA-approved amount found in popular non-prescription brands, and it may not even work at much higher doses.

Researchers at the University of Florida are asking the FDA to remove oral phenylephrine from the market. "We think the evidence supports that phenylephrine's status as a safe and effective over-the-counter product should be changed," says Randy Hatton. "We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people."

In 1976, the FDA deemed a 10 milligram oral dose of phenylephrine safe and effective at relieving congestion, making it possible for companies to use the ingredient without conducting studies. But Leslie Hendeles and Hatton say phenylephrine does not effectively relieve nasal stuffiness at this dose. They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers. In contrast, the FDA cited six tests demonstrating no significant difference between phenylephrine and placebo. Hendeles said a higher dose may work, but no research has been published regarding safety at higher doses. "They need to do a dose-response study to determine at what higher dose they get both efficacy and safety," says Hendeles adding that until then "consumers should go that extra step and get it (pseudoephedrine) from behind the counter."


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  • (Score: 4, Insightful) by ledow on Tuesday October 27 2015, @05:00PM

    by ledow (5567) on Tuesday October 27 2015, @05:00PM (#255178) Homepage

    I'm having difficulty imaging where a blocked ear/nose becomes in any way more than nuisance. Like a headache. Man, a headache can stop you driving, and make you pull over and want to sleep (if you're lucky). A sore throat can rob you of your voice and/or make you want to say nothing for a week. Migraines can be killers that severely affect your ability to operate as a human for several days. And sinus, yes, can affect you but nowhere near the latter of that list.

    But a blocked ear? Going to an ENT? Really?

    You're treating DISCOMFORT like it's an INJURY. That's not right. And the more times you do that, the less effective it will be and the more drug you will need. It doesn't matter if it's aspirin or paracetamol or something much more powerful, over time you're just making yourself immune to drugs that MIGHT help you because of discomfort. Hell, even morphine etc. is something that you can become virtually immune to quite quickly. How do you think your body handles a bi-monthly tinge of extremely low-dose paracetamol for years on end whenever you're feeling a bit under the weather? After a while, it's just NOT GOING TO WORK.

    And we ban substances not because they are no longer helpful. It's because people abuse them, and in a certain percentage even the first hit can affect you severely. Just going by people I know, for instance, "dope" certainly deserves its moniker. Totally unscientific but I can attribute a great dulling of the intellect for those people coinciding with a regular take-up of something as "harmless" as dope. MDMA etc. are whole different ball games.

    Try living in a country that doesn't profit from your illness - where ineffective shit is at your own cost, proven-effective but expensive cancer drugs are free, and treating a temporary and minor symptom is regarded as doing you a disservice. And where you'd be laughed out of the hospital or doctor's office for a blocked Eustachian tube that hadn't been like that for at least a month. Whoops, you probably voted against a national health service in your country, didn't you?

    Fucking medical intervention because you have a blocked nose...

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  • (Score: 3, Insightful) by MrNemesis on Tuesday October 27 2015, @05:32PM

    by MrNemesis (1582) on Tuesday October 27 2015, @05:32PM (#255197)

    I'm having difficulty imaging where a blocked ear/nose becomes in any way more than nuisance... You're treating DISCOMFORT like it's an INJURY.

    When the missus has blocked sinuses, you can't understand what she's saying and she can't hear what you're saying, and all the time with a splitting headache. You can't function like a normal human being and she certainly can't do her job when it happens. A blocked nose very definitely isn't the same thing as blocked sinuses so please walk a mile in someone else's shoes before you proclaim their problems are false.

    --
    "To paraphrase Nietzsche, I have looked into the abyss and been sick in it."
    • (Score: 3, Informative) by tonyPick on Friday October 30 2015, @11:52AM

      by tonyPick (1237) on Friday October 30 2015, @11:52AM (#256425) Homepage Journal

      I'd also add loss of balance as a major problem - as in "cannot lie down without having to hang on to the floor". I've had this once, and it took me out completely for a couple of days couldn't walk, stand up, etc.. The deafness, pain and discomfort was on the edge of manageable, but the balance problems were completely disabling.

  • (Score: 2) by bradley13 on Tuesday October 27 2015, @07:26PM

    by bradley13 (3053) on Tuesday October 27 2015, @07:26PM (#255248) Homepage Journal

    I'm having difficulty imaging where a blocked ear/nose becomes in any way more than nuisance... Man, a headache can stop you driving

    Nah, I never get headaches that bad, I'm sure you are exaggerating /sarc

    A cold causes pressure in their ears that makes it feel like someone is driving a knitting needle through their head. Just because you aren't one of the unfortunate ones doesn't mean the problem doesn't exist. Anyway, what's wrong with treating symptoms to make oneself less uncomfortable?

    we ban substances not because they are no longer helpful. It's because people abuse them

    Um...no? I don't think anyone trips out on pseudo-ephedrine. If you want to outlaw something, outlaw meth, not the precursor. Should we outlaw fertilizer, because you can build bombs with it? Did you know that you can make a pretty good bomb with flour? Maybe we should outlaw that too. Just because a few meth heads buy pseudo-ephedrine, why should be prevent millions of people from getting effective relief from colds and allergies?

    --
    Everyone is somebody else's weirdo.
    • (Score: 2) by meisterister on Wednesday October 28 2015, @12:41AM

      by meisterister (949) on Wednesday October 28 2015, @12:41AM (#255362) Journal

      Nah, I never get headaches that bad, I'm sure you are exaggerating /sarc

      Looks like you need to join the glorious migraine master-- AAAUUUGH I CAN'T SEE YET THE LIGHT HURTS

      --
      (May or may not have been) Posted from my K6-2, Athlon XP, or Pentium I/II/III.
  • (Score: 3, Informative) by DECbot on Tuesday October 27 2015, @08:19PM

    by DECbot (832) on Tuesday October 27 2015, @08:19PM (#255264) Journal

    The wife had a sinus infection that caused a 2-week headache with the occasional migraine and then a ruptured ear drum complete with blood coming out the ear. So, the DISCOMFORT did became an INJURY. I encouraged her to see the doctor long before the ear ruptured, but she thought it was too inconvenient.

    --
    cats~$ sudo chown -R us /home/base
  • (Score: 1, Informative) by Anonymous Coward on Wednesday October 28 2015, @02:59AM

    by Anonymous Coward on Wednesday October 28 2015, @02:59AM (#255408)

    Ah yes, the good old "I've never had this problem so why should anyone else"?