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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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) by jdavidb on Tuesday October 27 2015, @02:32PM

    by jdavidb (5690) on Tuesday October 27 2015, @02:32PM (#255103) Homepage Journal

    For those of us who depend on sudafed, this is not news.

    One night years ago in Chicago I stumbled into a Target at 10:00 P.M. and bought Sudafed I was in desperate need of. I was being a bit melodramatic, but I was so terribly ill that being able to breathe again felt like it saved my life. Shortly afterward, the law put sudafed behind the pharmacy counter. Good luck buying it at 10:00 P.M. now.

    --
    ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
    Starting Score:    1  point
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  • (Score: 3, Insightful) by Runaway1956 on Tuesday October 27 2015, @03:03PM

    by Runaway1956 (2926) Subscriber Badge on Tuesday October 27 2015, @03:03PM (#255119) Journal

    I went wandering around the web a little, trying to find pseudoephedrine availability and prices. Most hits are for "Sudafed PE". Almost all other hits are for "generics" that make use of the well-known Sudafed name. Everything rhymes with "pseudoe" something. The only "readily available" source I find, is the local Walmart pharmacy. And, the wife informs me that it's simply not available at Walmart most of the time.

    Imagine that - in effect, we have prohibition of a known effective treatment for a miserable condition. Our government excels at prohibiting things, with or without cause.

    • (Score: 2) by MrNemesis on Tuesday October 27 2015, @03:23PM

      by MrNemesis (1582) on Tuesday October 27 2015, @03:23PM (#255129)

      Probably out of your reach, but it's perfectly easily available over the counter in the UK. Here's some of the branded stuff [boots.com] and here's Boots' generic [boots.com]. The missus has occasional sinus problems and was told by the pharmacist to try a bunch of the phenylephrine crap, they did nothing and her doctor told her that this was frequently the case. But just go into any chemists and ask for a pseudoephedrine-based decongestant and you'll either get Sudafed or one of the generics.

      Maybe it's because meth isn't very popular here (perhaps because it's too easy to get your hands on "proper" drugs...?).

      --
      "To paraphrase Nietzsche, I have looked into the abyss and been sick in it."
      • (Score: 2) by Runaway1956 on Tuesday October 27 2015, @04:00PM

        by Runaway1956 (2926) Subscriber Badge on Tuesday October 27 2015, @04:00PM (#255150) Journal

        Interesting - apparently, though, the product must be signed for, after the pharmacist agrees that it is "suitable".

        Product description

        This Medicine is sold by BOOTS UK LIMITED at the professional discretion of a Boots pharmacist.

        Unfortunately, next day home delivery is unavailable for this product.

        Please note that you must be in to sign for this delivery.

        We need to ensure that this medicine is suitable for the person it is intended for. Therefore a Boots pharmacist may be required to contact you by phone to find out some additional information. If they are unable to speak to you when required your order may be delayed or the pharmacy medicine part of your order cancelled.

        Please ensure your contact details are correct before ordering this medicine.

        • (Score: 2) by MrNemesis on Tuesday October 27 2015, @05:08PM

          by MrNemesis (1582) on Tuesday October 27 2015, @05:08PM (#255183)

          Aye, links were there mostly to show their availability. I have a chemists right next to work and another a stones throw from home, if you want pseudoephedrine the pharmacist will ask if you've taken it before, how often, and ask what other medicines you're taking so they can gauge side effects. No idea what the procedure is like for buying on the internet but they certainly don't give a hoot about asking for ID in the shop and their policy over the internet just appears to mirror the pharmacists "duty of care" obligations. Looking at other over-the-counter medicines on their site (e.g. codeine) and they've got the same blurb.

          --
          "To paraphrase Nietzsche, I have looked into the abyss and been sick in it."
        • (Score: 4, Informative) by TheRaven on Tuesday October 27 2015, @06:27PM

          by TheRaven (270) on Tuesday October 27 2015, @06:27PM (#255222) Journal

          apparently, though, the product must be signed for, after the pharmacist agrees that it is "suitable".

          Nope. It must be signed for if you have it delivered (i.e. they won't just stick it in the post to a random address with no guarantee that it went to the right person). You can walk into a branch of Boots, ask for it, pay cash, and walk out. I know, because I did this a few weeks ago when I had a horrible cold-like thing. The pharmacist did check that I'd taken it before and knew about doses and things, but there was no requirement to be recorded. There might be if I tried buying it in huge quantities.

          --
          sudo mod me up
          • (Score: 2) by Runaway1956 on Tuesday October 27 2015, @07:13PM

            by Runaway1956 (2926) Subscriber Badge on Tuesday October 27 2015, @07:13PM (#255243) Journal

            Cool. Obviously, then, you have less control imposed on you than we do over here. Well, in this one respect, anyway.

      • (Score: 4, Informative) by Whoever on Tuesday October 27 2015, @04:10PM

        by Whoever (4524) on Tuesday October 27 2015, @04:10PM (#255158) Journal

        Probably out of your reach, but it's perfectly easily available over the counter in the UK.

        But you still have to ask the pharmacist in order to buy it:

        This Medicine is sold by BOOTS UK LIMITED at the professional discretion of a Boots pharmacist.

        Some context: until recently, the USA had only two categories of drugs*: prescription required and ON the shelf. The UK has had 3 categories for as long as I can remember: prescription required, over the counter (at the discretion of the pharmacist) and on the shelf. What has happened is that the restrictions on the sale of pseudoephedrine have created a third category in the USA, similar to the UK's "over the counter (at the discretion of the pharmacist)".

        So, the situation in the USA for buying pseudoephedrine is now the same as in the UK.

        *Someone is probably going to correct my my naive interpretation of what I have experienced buying drugs isn't correct and there are more categories, but for most purposes, there are two categories.

        • (Score: 1, Interesting) by Anonymous Coward on Tuesday October 27 2015, @04:18PM

          by Anonymous Coward on Tuesday October 27 2015, @04:18PM (#255163)

          > What has happened is that the restrictions on the sale of pseudoephedrine have created a third category in the USA, similar to the UK's "over the counter (at the discretion of the pharmacist)".

          Not so much "discretion of the pharamcist" in the USA, its "put your name on the watchlist." [wikipedia.org]

        • (Score: 2) by MrNemesis on Tuesday October 27 2015, @05:21PM

          by MrNemesis (1582) on Tuesday October 27 2015, @05:21PM (#255191)

          So, the situation in the USA for buying pseudoephedrine is now the same as in the UK.

          Aye, but the context I took from Runaway's post was that although pseudoephedrine-based decongestants were technically available over the counter, they were almost never stocked - presumably because of either the connotation or connection with meth production.

          You're right in the UK having three classificaions, noted here [wikipedia.org] and the section for the USA seems to agree with your thesis that there's a sort of pseudo(ha!)-third category in the USA now as well, but from the descriptions in the thread it seems in the UK this means "pharmacist makes sure you're buying the right medicine and aren't going to kill yourself by mixing it with XYZ" whereas in the US it seems to mean "chemists sez no". Not trying to say that's the way it is rightpondian, just the way I'm reading it.

          --
          "To paraphrase Nietzsche, I have looked into the abyss and been sick in it."
          • (Score: 0) by Anonymous Coward on Tuesday October 27 2015, @05:28PM

            by Anonymous Coward on Tuesday October 27 2015, @05:28PM (#255195)

            Aye, but the context I took from Runaway's post was that although pseudoephedrine-based decongestants were technically available over the counter, they were almost never stocked - presumably because of either the connotation or connection with meth production.

            He gave you the wrong impression. They are stocked, but the pharmacist goes home at 5pm or 6pm. Lots of people in the US use in-store pharmacies that are open much later than the pharmacy itself. You can still browse the OTC stuff on the shelves and there are often "placeholder" boxes for the sudafed - you bring the empty box to the pharmacist and trade it for the real thing - and the pharmacist types your ID info into their computer.

      • (Score: 2) by Phoenix666 on Wednesday October 28 2015, @12:38AM

        by Phoenix666 (552) on Wednesday October 28 2015, @12:38AM (#255360) Journal

        That's why when I travel to developing countries I stock up on stuff I know I'll use, like real Sudafed.

        --
        Washington DC delenda est.
    • (Score: 2) by AndyTheAbsurd on Tuesday October 27 2015, @04:38PM

      by AndyTheAbsurd (3958) on Tuesday October 27 2015, @04:38PM (#255168) Journal

      Do you not have a CVS or Walgreen's location in your area? Both of those sell it, both in original-formulation Sudafed and generic equivalents. I'd bet other most chain pharmacies do as well - I'm pretty sure that I've bought it at Target's pharmacy before, if you've got one of those. Yes, the prices may be a little bit more than Wal-Mart's - but the (literal) price you pay for not having to go to Wal-Mart.

      --
      Please note my username before responding. You may have been trolled.
      • (Score: 2) by Runaway1956 on Tuesday October 27 2015, @05:07PM

        by Runaway1956 (2926) Subscriber Badge on Tuesday October 27 2015, @05:07PM (#255181) Journal

        In SW Arkansas, there's a Wally World in every town. Walgreens and Target are both available in Texarkana. That translates into a 20 minute drive when the wife goes to the closest Walmart, vs a one hour drive into Texarkana, then fighting with traffic. And, of course, again you may or may not find the Sudafed is actually available. And, double of course, you'll still have to present an ID, and hope the pharmacist sells the stuff to you.

        It's been quite a long time since I've actually gone "shopping" in Texarkana. They've built up an entire shopping district on the west side (Texas) side of town. There are probably other pharmacies I could find Sudafed. Again, I'll be ID'd, blah blah blah.

        Now - funny thing is, I found the stuff available from outside the country, for $14/28 capsules. So, if a person wants to avoid US/UK restrictions, he can order it from Eastern Europe. Wonder if the FBI or DEA would come knocking on my door if I did that? The price isn't right, but it's available.

        • (Score: 2) by AndyTheAbsurd on Tuesday October 27 2015, @05:43PM

          by AndyTheAbsurd (3958) on Tuesday October 27 2015, @05:43PM (#255206) Journal

          20 minutes just to get Wal-Mart? Man, that sucks - I've got two that I can get to in less than that (probably 15 minutes, unless traffic is really bad), and they're both supercenters. Not that I ever go - I hate Wal-Mart, partially for their politics, partially for driving small businesses out of business - which is the reason that you've got to drive an hour-plus to find a Target. Of course, in your area, NOT shopping at Wal-Mart probably isn't an option, since it's likely that now they're the only store in town for most retail purchases.

          --
          Please note my username before responding. You may have been trolled.
          • (Score: 2) by Runaway1956 on Tuesday October 27 2015, @05:56PM

            by Runaway1956 (2926) Subscriber Badge on Tuesday October 27 2015, @05:56PM (#255211) Journal

            "since it's likely that now they're the only store in town for most retail purchases."

            That grows more and more true, all the time. Brookshire's has always been my favorite grocery store, since I moved to this area. They used to have a store in every one of the surrounding towns. Gone, gone, and gone, another one losing business steadily, and the last one only doing modest business. The wife now does about half of her shopping at Wally World, depending on which direction she chooses to go.

            Pharmacies are the hardest hit. For over twenty years, Walmart has moved into a town, sold drugs below cost, waited for the local pharmacy to go bankrupt, then jacked prices up to competitive levels, if not slightly higher than competitive.

            From your own post, you understand very well why I hate Wally World.

            • (Score: 2) by jdavidb on Wednesday October 28 2015, @01:11AM

              by jdavidb (5690) on Wednesday October 28 2015, @01:11AM (#255372) Homepage Journal
              Wal-Mart and Brookshire's? You and I must be neighbors.
              --
              ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
          • (Score: 0) by Anonymous Coward on Tuesday October 27 2015, @07:56PM

            by Anonymous Coward on Tuesday October 27 2015, @07:56PM (#255259)

            drive an hour-plus to find a Target

            So, your alternative is another business that uses corporate profits to fund Reactionary organizations? [google.com]
            ...and you have to go out of your way to do that.

            Either I'm missing your logic or where you are you are simply stuck with the lesser of 2 evils.

            Don't you have any locally-owned businesses where you are?

            -- gewg_

  • (Score: 1) by PocketSizeSUn on Tuesday October 27 2015, @06:53PM

    by PocketSizeSUn (5340) on Tuesday October 27 2015, @06:53PM (#255233)

    I occasionally suffer from blocked sinuses. I used to use Sudafed or a generic. Usually occurs when I have been short on sleep for too long (or maybe just too idle sitting in front of a computer screen).
    Regardless of the reason for the trigger, sometimes I don't have access to a decent decongestant. I tried nasal saline flush and that works well. It can be a bit tricky to do on-the-fly as it were so now I have resort to just snorting a small amount of table salt. Hurts like hell but it works fast and lasts longer than pseudoephedrine. Better than letting the sinus block trigger a damn migraine .. those are hell.

    YMMV but if you are desperate getting you hands on a salt shaker or packet is often relatively easy.

  • (Score: 0) by Anonymous Coward on Tuesday October 27 2015, @09:53PM

    by Anonymous Coward on Tuesday October 27 2015, @09:53PM (#255293)

    When I was younger, before Rhinocort burned my passages clear, I was visiting relatives in the country when I caught something nasty. I waited overnight for the town pharmacy to open. When it did I had a nasty shock. No sudafed. WTF. I knew how to fix that problem. Take sudafed and ride it out. They refused to sell me a box of sudafed. Told me it was better to let my nose run constantly for days. Assholes. My sinuses were bad enough without their "help". Then sudafed was taken off the shelves. For the few times I need it, I now wish I had stocked up.