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posted by cmn32480 on Tuesday October 27 2015, @02:24PM   Printer-friendly
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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."


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  • (Score: 0) by Anonymous Coward on Tuesday October 27 2015, @05:28PM

    by Anonymous Coward on Tuesday October 27 2015, @05:28PM (#255195)

    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.