FDA panel finds that the decongestant phenylephrine does not work

I was sick last week with cold symptoms. I tried taking phenylephrine decongestants and felt like I may as well have taken a sugar pill. I’ve always felt that way. Growing up I had acute sinusitis and was constantly getting sick, so I consider myself a connoisseur of decongestants, cough suppressants, NSAIDs, and various home remedies, as well as combinations of these. I can talk about cold medicine the way that a sommelier describes wine. The phenylephrine always seemed to do nothing except make me both drowsy and unable to fall asleep. Now I feel completely vindicated because an FDA advisory panel just admitted that phenylephrine doesn’t work after all. It has poor bioavailability. Your body breaks it down before it can get into your bloodstream. Now the FDA has to decide whether to remove or ban products containing the medication.

On Tuesday, a Food and Drug Administration (FDA) advisory panel released new findings that revealed one of the key ingredients found in many over-the-counter health products doesn’t relieve congested individuals of the issue after all.

Phenylephrine — which is commonly found in over-the-counter medications used to treat nasal congestion — is now considered ineffective. The ingredient was marketed as a decongestant used to treat stuffy noses, sinus congestion and pressure.

It was also previously believed to reduce swelling of blood vessels in nasal passages.

“It has poor oral bioavailability because of extensive first-pass metabolism in the gut and liver,” The Journal of Allergy and Clinical Immunology reports.

The findings were unanimously determined after a vote was held and the revelation could reshape the billion-dollar over-the-counter healthcare industry as we know it, NBC News reported.

According to The New York Times, the FDA will likely have to make the decision on whether to remove the ineffective products or ban them. The outlet noted that the process could take months, even longer if the results are contested.

For the United States, some of the most commonly used brands that list phenylephrine as the active ingredient include Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief and Benadryl Allergy Plus Congestion.

CNN adds that together, the medications generated almost $1.8 billion last year, citing data that the Nonprescription Drugs Advisory Committee was given on Monday during a two-day meeting.

Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy in North Carolina, is a member of the committee and spoke out after the information was publicly released.

The evidence is “pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion,” Blalock said.

[From People]

I’m glad they figured this out (and, in my typical Aries fashion, I am overjoyed that I have been right about this all along). But I’m also annoyed that phenylephrine has been on the market all this time and hasn’t been doing anything for people. My dad has the same sinus problems as I do and he would take that medication sometimes but it was probably bad for his high blood pressure. Granted, drugs like Sudafed (pseudoephedrine) or Afrin (oxymetazoline) are also bad for his blood pressure but at least they work, you know? At least the trade off is worth it for some temporary relief.

This is simply further proof to me that the FDA needs to spin itself off into two agencies, one for food safety and one for drugs. I just think an agency with such broad responsibilities across multiple industries is bound to slip up, like with this issue or the recent infant formula fiasco. Politico has weirdly good reporting about the formula shortage and this article also hints at “constant turmoil” within the organization as departments compete for limited resources. It just seems like there need to be big structural changes at the agency. Then again, I know nothing about public policy. But if you want a person at the bar to stop bothering you, just start talking about the bureaucratic gridlock at the FDA because it bores people to tears. I use this talking point all the time to get men to leave me alone and it never fails.

photos credit: Andrea Piacquadio, Mikael Blomkvist on Pexels and via Instagram

You can follow any responses to this entry through the RSS 2.0 feed.

22 Responses to “FDA panel finds that the decongestant phenylephrine does not work”

Comments are Closed

We close comments on older posts to fight comment spam.

  1. CL says:

    I heard this story on NPR and started laughing, because I had just returned from Walgreen’s, where I had purchased original Sudafed and Mucinex. I tried the other Sudafed a few times, and it never worked for me. At least now other people know!

    • Drea says:

      Yup, never used it because it never worked. Only the real sudafed for me! (Also always with Mucinex, it’s a magic combination)

  2. Indica says:

    I gave up on this stuff years ago… it just doesn’t work. If I get a nasty sinus headache, original sudafed is the only thing that works for me.

    • manda says:

      same, original sudafed is the only thing that works, and I do take it kind of frequently. I’ve talked to my doctor about it and my BP is fine. None of the high blood pressure OTC pills worked.

      sidenote–has sudafed been changed since like the 90s? because it used to make me super drowsy, and it doesn’t anymore

      • Drea says:

        Sudafed made you drowsy? Are you confusing it with Benadryl?

        It’s one of the main ingredients to meth. Nah girl, that won’t make you drowsy.

        Sudafed has been pseudoephedrine since as long as I’ve been around, at least. And that’s a long while.

  3. Neners says:

    I’ve refused to take any cold medicine with Phenylephrine as the decongestant for years. I’d rather have to go up to the pharmacist and give my license to get real pseudoephedrine or just take nothing at all. It pisses me off that these useless decongestants have been allowed to proliferate for so long.

    • Cate says:

      Same. It’s annoying to have to go to the pharmacy counter and show ID and all, but this stuff is not worth the cardboard box it’s packaged in.

      • kirk says:

        To be fair to the pharma industry, they tried to come up with something to take the place of pseudoephedrine products that were being used as precursor for making methamphetamine (meth). There was a reason for creating a substitute! They tried something and it didn’t really work well as a decongestant. This has been common knowledge for ~15 years. Try drinking more fluids and making your own salt spray nose drops.

  4. FHMom says:

    Literally anybody who has taken it, can tell you it doesnt work. I bought the real Sudafed behind the counter.

  5. Kebbie says:

    At least once a year my mom will get sick, take regular DayQuil, and then complain to me that it’s not working. I’ll explain to her for the 50th time that phenylephrine is useless and she needs something with pseudoephedrine. Then she gets better and forgets about it until her next cold when I get the “this DayQuil is not helping at all!” text from her.

    I can’t wait for the FDA to ban this stuff if only so it’ll stop the companies from claiming their medications help with congestion! Sending this news to my mom now…it will no doubt come as an absolute shock to her lol

  6. FancyPants says:

    I hope they didn’t spend a lot of money figuring this out. I could have told them for free that the phenylephrine doesn’t work based on the years I lived in Mississippi and the psudoephedrine was only available by prescription, so I was stuck with the PE stuff unless I made a doctor appointment.

  7. Naye In VA says:

    Why be amazed that it’s been on the market for so long? People kept returning to buy more because it wasn’t working lol. Companies raked in the dough.

  8. MJM says:

    I live in Canada. Back in the earlier 2000’s I was on a road trip to the states and was experiencing sinus trouble so purchased some Sudafed. Was completely shocked that it did nothing but make me feel weird. I checked the ingredients and was like “what is this shit?” I am always careful to make sure I get pseudoephedrine now as that useless stuff is still included in some preparations here.

  9. StellainNH says:

    When I get colds or have congestion from allergies, I use a saline nasal spray. No side effects, and it feels like I get over my cold faster using the saline spray.

  10. Whyforthelove says:

    Hey FDA… we knew this but thanks!

  11. Jackie Darlin’ says:

    Pharmacist in Canada here. Have been having this conversation with patients since 2009. Had a patient last night, wanted a specific product which had phenylephrine. Tried to steer her to one that had all the same ingredients except pseudoephedrine instead. Told her it’s more effective. She had vaguely heard about this news but couldn’t remember any specifics (I had not seen this announcement at all yet). She ended up buying both so she could test it out herself; you learn to let people make their own (bad) decisions. Thanks for catching me up on the news, I’ll definitely be getting more questions about it.

    • SophieJara says:

      Pseudoephedrine changed my life. I used to get sick for months at a time, but I had never been to a pharmacy (except once for antibiotics). My mom is a big homeopathy and herbal tincture person. When I was 27 I finally went to the college health center for a terrible cold that wouldn’t quit and they explained sinus infections to me and why decongestants are important. I was fairly terrified (lifetime of being told western medicine will ruin my liver and my body’s resilience), and my pharmacist was SO kind and helpful and patient with me. Pharmacists are the best!

    • StellainNH says:

      My dad was a pharmacist and growing up, the only OTC we had in the house was aspirin. He always said that the cold remedies out are designed to make you feel miserable, after all, with a cold, you should feel terrible. I found that using a saline nasal spray is most effective. It seems to cut down the length of my cold.

  12. wolfy says:

    I have had a different experience. I have never used the oral type, but in a nasal spray, the fast acting ones with phenylephrine are the only ones that work for me. The 12 hour ones with oxymetazoline do absolutely nothing for me.

  13. amadabasura says:

    I can’t take Sudafed and all and phenylephrine works for me. It doesn’t work well, but it saved me from a 5th sinus procedure this summer. Just because it doesn’t work for others doesn’t mean I shouldn’t be allowed to take it. I’m not advocating for Sudafed to be removed from the market just because I can’t use it but maybe I should start.

  14. LynnInTx says:

    Interesting. I’ve always used Alka-Seltzer severe, which has phenylephrine in it, but it works (well enough) for me. The pseudoephedrine from years ago always did work much better, it’s just that most of the time, they don’t even have it behind the counter here, so I take what relief I can get. Perhaps there is a difference between the normal pills and Alka-Seltzer. I can’t take Mucinex at all. I’m one of the rare percentage of people that gets hallucinations on it from the guaifenesin (and not fun ones).

  15. Lisbeth says:

    Thank you for this article, it was very informative!