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The Popular Over-The-Counter Cold Medicine That Science Says Doesn't Work (forbes.com)
HughPickens.com writes: 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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."
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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."
Anyone who has taken a product sans pseudoephedrine already knows they don't work.
Everyone knows PE doesn't work. It's only there so the government can claim they haven't removed all the useful OTC decongestants from the market. Yes, technically you can still buy pseudoephedrine in most states, but doing so puts you on a list which gives them probable cause to bust down your door on suspicion of meth manufacture.
... is that crystal meth is relatively easy to obtain, and it can be converted to Sudafed. Now all we need is for researchers to simplify the process and provide a practical process for the layman.
Yeah but pseudoephedrine relieves all congestion, not just nasal.
While the FDA is at it, can they please tackle all the other snake-oil products at the drug stores? All the homeopathic crap, Airborne Head On, magnet bullshit, diet pills, etc. They are all 100% bullshit placebos.
I have ridiculous allergies, and take a number of antihistamines to keep them in check (but hey, the asthma is enough in check that I can run, so I'm happy.)
Try eating a tablespoon a day of locally produced honey, unfiltered, for a month or so. The beekeeper should be the closest one to your home you can find, though even 100 miles out still ought to work.
Sending the local pollen through your digestive tract gives your immune system another shot at getting used to pollen without causing respiratory problems. I used to have terrible allergies that could barely be controlled by double doses of claritin. I still have allergies, but they're much milder and much more controllable by medication.
It's a pretty low-cost, low-risk home remedy. I stumbled across it when I was doing an internet search for "Is it safe to take double doses of Claritin?", and I figured 'What the hell, it's not like honey is expensive or dangerous.'
Alcohol, Tobacco and Firearms should be the name of a store, not a government agency.
Afrin is pure, unadulterated evil. It is, far and away, the best decongestant on the market, bar none. It is also over the counter.
It is wrong, IMO, to describe it as addictive due to the connotations of that word. There are no cravings that result from Afrin use. No one is going to feel a compulsion that they "just gotta have it". No junkie related crime. What *does* happen is that your body starts to rely on Afrin to keep the airways clear. Without it, you are stopped up and cannot breath. Even worse, after prolonged use the efficacy of Afrin is decreased. So eventually you will be using it three shots each nostril several times a day and still not be able to breathe.
Thankfully, you *can* wean yourself off of Afrin. It is miserable, however, and not likely something you want to go through. The sooner you start the better. Although I've never had the misfortune to abuse Afrin like that I've known multiple people who have. At the beginning they talk about how wonderful it is (and it doesn't hurt that it is "just over the counter" so "it must be safe"), then they have to recover from it. I have significant long term breathing issues and at least twice a year I have to use Afrin for a few days in a row. Even at that I eventually noticed a diminishment of effect.
The fact that something so debilitating, so damaging to the user's health, is sold over the counter while other less harmful drugs are strictly regulated says a lot about the true functioning of the FDA.