Well, this is interesting. What will we do for cold and flu season? I am well aware that you can still buy pseudoephedrine from behind the counter but is a pain in the bohonkus to do that. Anyway, this is an interesting article.

I can't believe the $$$ I've spent over the last number of years trying to find relief and been sold this supposedly ineffective crap. It never worked for me anyway.


"FDA Advisory Panel Rules that Oral Phenylephrine Is Ineffective

Jennifer Middleton, MD, MPH
Posted on September 25, 2023

A recent U.S. Food and Drug Administration (FDA) advisory panel has concluded that over-the-counter (OTC) oral phenylephrine is ineffective as a nasal decongestant. This finding is not especially surprising, as oral phenylephrine’s effectiveness has been questioned for decades. The FDA, though, must now decide whether to require phenylephrine’s removal from OTC cough and cold products, which may "significantly disrupt the market for the makers of cold medicines” and confound our patients looking for relief from common cold symptoms as the U.S. heads into fall and winter.

The Combat Methamphetamine Act of 2005 moved pseudoephedrine, which is quite effective for the temporary relief of nasal congestion, behind the counter of U.S. pharmacies. Pseudoephedrine was being used to produce illicit methamphetamines, and the U.S. Drug Enforcement Agency (DEA) wanted to limit its access. This restriction on pseudoephedrine, however, has not decreased the use of illicit methamphetamines in the U.S.. Pseudoephedrine is available in most of the U.S. without a prescription, though a few states require a prescription. It is now stored behind pharmacy counters, and purchasers must show a U.S. driver’s license or identification card. Understandably concerned about the effect of this change on sales, OTC cold and cough medication manufacturers quickly reformulated their products with phenylephrine instead (for example, “Sudafed” went behind the counter but “Sudafed PE” sits on drugstore shelves). Unfortunately, purchasers of these phenylephrine products likely did not experience any improvement in their nasal congestion; “‘[i]f you have a stuffy nose and you take this medicine, you will still have a stuffy nose.’”

Phenylephrine may be ineffective but it’s not dangerous in OTC doses, and patients with common cold symptoms may still find some relief from the other ingredients in multi-product formulations. It should be noted that nasal phenylephrine was not included in this review and is effective for nasal congestion. We can help our patients navigate viral upper respiratory tract infections (URIs) by reminding adult patients that “[t]reatments with proven effectiveness...include over-the-counter analgesics, zinc, nasal decongestants with or without antihistamines, and ipratropium for cough”. The list of safe and effective treatment options in children with URIs includes "acetylcysteine, honey (for children one year and older), nasal saline irrigation, intranasal ipratropium, and topical application of ointment containing camphor, menthol, and eucalyptus oils,” and we should remind parents and caregivers that children under the age of 4 years should not use any OTC cold products. Vaccinations for influenza, COVID, and RSV reduce morbidity and mortality, and handwashing remains the best prevention for all of these viral illnesses.

You can find more information about the FDA advisory committee’s review of phenylephrine effectiveness data here. The DEA website has information on dextromethorphan, another OTC cough/cold medication with abuse potential. And, AFP has plenty of resources for you as we head into the colder months in the Northern hemisphere: the AFP By Topic on Respiratory Tract Infections includes resources for physicians and patients on the common cold and RSV, and there are also AFP By Topics on Influenza and COVID-19.

Disclaimer
The opinions expressed here are those of the authors and do not necessarily reflect the opinions of the American Academy of Family Physicians or its journals. This service is not intended to provide medical, financial, or legal advice. All comments are moderated and will be removed if they violate our Terms of Use."

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If the FDA hates oral phenylephrine, that stuff must cure cancer, fight the flu, and obliterate obesity.

This is the stuff they switched to around 15 or 20 years ago, right?

I’ve noticed too that it doesn’t really work.

Before they started using this stuff, the standard NyQuil and Sudafed used to work well, and then they started using this Phenylephrine stuff and it no longer worked for me.

Around ten years ago a pharmacist told me it doesn't work nearly as well as the 'behind the counter' version. It's sold well for a long time, though. Maybe this was simply a response to replace the product that worked to keep a profitable product going.

I stopped buying that junk years ago. It was absolutely worthless. Scolded the wife more than once when she went for Sudafed and came back with it.

Nothing beats the little red 4-hour real deal. Just like nothing beats codeine for a cough, but good luck getting decent cough syrup in the last decade+.

Remember kids: "Safe and effective. Trust The Science"

Anything of that nature sold in the US has to gain FDA approval which requires clinical trials, etc.

Is this another one of those rush jobs that was never fully tested but we had to get it on the market (opposite of what is supposed to happen) or where the tests somehow falsified?

Why are we finding out about this now?? One of the roles of the FDA is to assure drugs are effective as marketed and pose no danger.

FDA is Faking Data Anyway

^^^ That's for damn sure!