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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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: 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.