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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."
(Score: 2) by MrNemesis on Tuesday October 27 2015, @03:23PM
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
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
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
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
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
But you still have to ask the pharmacist in order to buy it:
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
> 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
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
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
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.