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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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: 2, Disagree) by ledow on Tuesday October 27 2015, @04:42PM

    by ledow (5567) on Tuesday October 27 2015, @04:42PM (#255171) Homepage

    Is it really just me that doesn't use any of this rubbish?

    Anything you take on a regular basis will soon become ineffective for you anyway.
    Anything you can get "without prescription" (i.e. over the counter) is practically useless (because it's so safe that it's actually difficult to even overdose on it without raising suspicions wherever you buy it).

    Cough and sore throat medicines - about as effective as honey.
    Headache tablets - very hard to ever demonstrate that your headache wouldn't have gone by the same time anyway.
    Cold remedies - basically a towel and a bucket of steaming hot water makes you feel the same, and it's only how you "feel" and making you a bit more comfortable, it doesn't make it last any less time.
    Decongestants - Get a bit of tissue, stuff it up your nose, and go about your day.

    I'm sure that if you're a migraine sufferer, or similar, that you don't want "over-the-counter" stuff anyway, but a proper migraine tablet that can stop it in its tracks if you get it quick enough (and if you're a sufferer, you will have that kind of stuff to hand most of the time), but all the "everyday" maladies are really not worth treating at all.

    I see people with bags full of "everyday" tablets, and they never seem to be in any less suffering than any one else. And some people take LUDICROUS amounts of these things. Literally a pack in their weekly shop every single time. At the low-dosages that they are, and that kind of prolonged exposure, they weren't doing anything after the first few weeks, let alone years later.

    Prescription medicines, yes, that's a totally different area, but even there when I've been prescribed things - if I don't have the symptoms they are combating, (e.g. pain for painkillers, etc) I stop taking them. Or if they aren't doing what they are supposed to (e.g. letting you sleep for sleeping tablets), I stop taking them. In fact, I very rarely ever take any tablets whatsoever. I've never taken a sleeping tablet in my life. I don't have prolonged headaches. Colds come and go with everyone and a tablet doesn't make you less symptomatic or less infectious in those cases.

    And yet when I get something, I'm far less symptomatic than those I got it from (or give it to!), and far less prolonged. It's commented on regularly by the people around me. X gets a really bad illness, Y gets it from X and suffers just as bad, I get it from Y and, yes, I get ill but nowhere near as bad or for as long, and then Z gets it from me and suffers like the first two. They all medicate, as a matter of course for every malady, and more so when they are actually badly ill, and I don't. I can't help but make a correlation there.

    Am I really the only person here thinking "Well, no, these things aren't doing much at all even in the best of circumstances and I'm not surprised that they are doing NOTHING at all either". Has nobody else honestly noticed this?

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  • (Score: 2) by VanderDecken on Tuesday October 27 2015, @04:57PM

    by VanderDecken (5216) on Tuesday October 27 2015, @04:57PM (#255175)

    I concur about the cough and decongestant related stuff. I gave up on cold medicines about a decade back, and instead take time off when I'm sick, drink lots (not ethanol :) and sleep. I find that the congestion may be worse but I get over things quicker. Besides, I found that cold medicines made me feel like crap anyway. And co-workers appreciate the fact that I'm not spreading things around.

    With respect to pain killers, I do find them effective. However I use them rarely and in moderation.

    --
    The two most common elements in the universe are hydrogen and stupidity.
  • (Score: 2, Interesting) by Anonymous Coward on Tuesday October 27 2015, @05:41PM

    by Anonymous Coward on Tuesday October 27 2015, @05:41PM (#255202)

    Is it really just me that doesn't use any of this rubbish?

    Anything you take on a regular basis will soon become ineffective for you anyway.

    Some people with allergies take sudafed regularly. But most people take it to treat symptoms for specific infections. I tried your idea and it fucked me up. Without sudafed snotfulf colds get progressively worse, I get weaker and start getting secondary infections like pink eye and I'm out of commission for a couple of weeks, sometimes with a doctor's visit. With sudafed I just feel kinda shitty for a couple of days and its over. I'm just a sample size of one, but that's been my experience and it has made me deeply bitter about this law.

  • (Score: 3, Insightful) by NotSanguine on Tuesday October 27 2015, @07:09PM

    Anything you take on a regular basis will soon become ineffective for you anyway.
    Anything you can get "without prescription" (i.e. over the counter) is practically useless (because it's so safe that it's actually difficult to even overdose on it without raising suspicions wherever you buy it).

    And so, when I have a sinus infection (once a year or less), I should just deal with the pain in my temples, the infected mucus as post=nasal drip causing me to hack, the pressure in my sinuses (think "ten pounds of shit in a five pound bag") and the inability to sleep due to these symptoms, you think I should just suck it up?

    Pseudoephedrine actually works to dry out my sinuses and allow me to function and sleep. This allows my body to fight the infection (and if it doesn't go away after a week or so, it's time for antibiotics).

    In many ways, I'm like you. If a bug bites me, it dies a slow, painful death. I'm rarely ill and have few (except for sulfa drugs) allergies. However, PSeudoepehedrine is a safe and effective decongestant. I have yet to find another which is effective *at all*.

    Just because your experience is different, doesn't mean that anyone who takes pseudoephedrine is wasting their time and money. Cheers for your good health and I wish you many long years of it. But your experience doesn't necessarily translate to everyone else.

    As an aside, you come off as lacking in empathy. Is that because you know folks who are hypochondriacs, or are you just a sociopath?

    --
    No, no, you're not thinking; you're just being logical. --Niels Bohr
    • (Score: 0) by Anonymous Coward on Wednesday October 28 2015, @01:22AM

      by Anonymous Coward on Wednesday October 28 2015, @01:22AM (#255376)

      > As an aside, you come off as lacking in empathy. Is that because you know folks who are hypochondriacs, or are you just a sociopath?

      I doubt he is a sociopath. Just someone who hasn't figured out that everybody is different, often significantly different and that his personal opinions are inherently no more valid than anyone else's personal opinions. The world is full of people like that.

  • (Score: 1, Informative) by Anonymous Coward on Tuesday October 27 2015, @08:20PM

    by Anonymous Coward on Tuesday October 27 2015, @08:20PM (#255265)

    Anything you take on a regular basis will soon become ineffective for you anyway.

    This statement is false. Some drugs become ineffective, others do not.

  • (Score: 2, Informative) by Anonymous Coward on Tuesday October 27 2015, @08:38PM

    by Anonymous Coward on Tuesday October 27 2015, @08:38PM (#255270)

    Anything you can get "without prescription" (i.e. over the counter) is practically useless (because it's so safe that it's actually difficult to even overdose on it without raising suspicions wherever you buy it).

    Acetaminophen aka paracetamol aka Tylenol, available on the shelf at your local walmart -- I went to the cupboard and found a bottle of 225 tablets of 650mg each. If you multiply that out, you'll see that it's 146g. So this one bottle (no suspicions raised) is about 4x the LD50 for a 100kg body. And of course that's for 50% lethality -- toxicity kicks in way, way sooner (starts around 5g dose for adults, increasing damage as the dose increases).

    So basically, bullshit.