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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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: 3, Informative) by DECbot on Tuesday October 27 2015, @08:19PM

    by DECbot (832) on Tuesday October 27 2015, @08:19PM (#255264) Journal

    The wife had a sinus infection that caused a 2-week headache with the occasional migraine and then a ruptured ear drum complete with blood coming out the ear. So, the DISCOMFORT did became an INJURY. I encouraged her to see the doctor long before the ear ruptured, but she thought it was too inconvenient.

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    cats~$ sudo chown -R us /home/base
    Starting Score:    1  point
    Moderation   +1  
       Informative=1, Total=1
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    Karma-Bonus Modifier   +1  

    Total Score:   3