Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.
If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
Glad to finally have official recognition of what I’ve known for 17 years. (But was always told “of course it works, they wouldn’t be allowed to sell it if it didn’t work” with bonus implication that I was trying to be special/unique by finding it useless.)
Yup, I’ve always had to buy the old stuff from behind the counter as the new stuff never worked.
I used it once then forever requested literally “anything else that doesn’t contain that placebo”.
Actually the nasal spray version works great. So they are idiots if they are talking about that. I use it all the time. Hope they do not discontinue that.
According to the article, they’re only discussing the oral medication. Apparently the metabolism process means that almost no phenylephrine gets into the bloodstream when taking orally.
Thanks. I did not see that in the article. The NYT article that someone else posted was more explicit. So I think you are correct. Hate to loose the nose spray version.
From the article:
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays or drops, and those products are not under review.
Yeah agreed. For oral meds, I always ask for the real pseudoephedrine behind the counter.
Yes, for oral pseudoephedrine works. Not sure why people just do not ask.
The thing about pseudoephedrine, it does not agree with me at prescription strength (not sure I ever had a problem with over the counter version). One time years ago I took prescription strength, if affect my eye muscles, just couldn’t focus. Kind of freaked me out, so I avoid. Just me.
My mom who was a nurse for 40 years has said the same thing for the past 15+ years or whenever they made the switch here in the US.
So…what are you supposed to take at this point? Because you’re not supposed to take the “nighttime” branded decongestants long term, and phenylephrine was recommended as an alternative to that.
The nasal spray form:
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays or drops, and those products are not under review.
Or just good old Pseudoephedrine, but you have to get it from the pharmacy counter even though it doesn’t require a prescription. (Thanks Meth producers) but AFAIU taking any decongestant long term is a bad idea. And Phenylephrine increases blood pressure.
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WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters.
This week’s two-day meeting was prompted by University of Florida researchers who petitioned the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion.
The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine’s original approval.
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion.
The group’s negative opinion opens the door for the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids.
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