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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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: 3, Informative) by M. Baranczak on Tuesday October 27 2015, @03:25PM
(Score: 5, Interesting) by SecurityGuy on Tuesday October 27 2015, @03:44PM
Oh, no. I absolutely hate that law.
I've never used recreational drugs, other than alcohol (in moderation, I don't like being drunk) and caffeine. No judgement there, you do what you want with your body and as long as it doesn't affect me, I don't care. Just my choice.
Now I have to sign some form with dire warnings about how I'll go to jail if I try to buy too much allergy/cold medicine. I have major problems with any law that criminalizes doing nothing wrong. The limit is high enough that I've never come close to hitting it, but if memory serves I figured once that hitting it with legitimate purchases is very possible if you're buying medicine for more than yourself. If you have kids, for example, which I do.
(Score: 2) by jdavidb on Tuesday October 27 2015, @06:13PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 2) by M. Baranczak on Tuesday October 27 2015, @08:35PM
I use the stuff so rarely, that I never even thought about the limit. So that's where my comment was coming from. I didn't know it was possible to reach the limit so easily.
(Score: 2) by jdavidb on Tuesday October 27 2015, @08:47PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 0) by Anonymous Coward on Wednesday October 28 2015, @12:48AM
What happens when you trip the limit? The police show up?
(Score: 2) by jdavidb on Wednesday October 28 2015, @01:01AM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 3, Insightful) by Hyperturtle on Tuesday October 27 2015, @11:25PM
Ding
I have chosen to suffer silently (and with difficulty breathing) than to sign up for the list. No, as a law abiding citizen I do NOT want to be on yet another list. That will likely never go away. If anything, people in China will find out I have allergies before my insurance company is willing to pick up the costs.
And I too want to know if the meth rates went down.
You'd figure that maybe if this stuff was available again, they can stock it at the pharmacies all the legal prescription opiate addicts go to, and maybe wake them up a bit and convince them to take up meth instead of heroin to justify the ban.
Which reminds me -- this isn't profitable. Maybe that is why its still banned or even got treated this way to begin with. There is no expensive alternative that works, though, not that I have heard of (not that I'd buy, knowing the cheap solution is locked up). The opiate drugs available via prescription are, which is why they are sold despite so much more evidence of the harm they are doing.
Oh yeah and they banned various plants that had the chemical in it too, because someone overweight might take too many concentrated extracts in pill form and die while failing to follow the label's instructions on how to safely consume it. Yet... the opiate market continues unabated.
I guess the opiates of the masses really are opiates.
(Score: 1, Interesting) by Anonymous Coward on Tuesday October 27 2015, @05:36PM
> Of all the stupid shit that the government makes me do, signing a form for Sudafed is really one of the least onerous.
Guess who the very first person they arrested under this law was?
A man buying medicine for himself and his son, [reason.com] both of whom had severe allergies.
That was an auspicious start.