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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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 jdavidb on Tuesday October 27 2015, @06:15PM
Because most of the time the people arguing for more freedom with respect to toxic substances, those are the people who most need to be old no.
It does not follow from this that it is acceptable to actually tell them no. If you don't want to sell them sudafed, don't sell them sudafed, but it doesn't become ethical to interfere in other people's private medical decisions simply because one believes some people need to be protected from themselves.
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 1) by Francis on Tuesday October 27 2015, @07:49PM
So the FDA and medical board are immoral? Are you reading what you've written?
(Score: 2) by jdavidb on Tuesday October 27 2015, @08:47PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings