The coming fall and winter seasons are projected to bring waves of respiratory illnesses such as colds, flus, COVID, and RSV. Since the list of viral infections isn't getting shorter, families are stocking up more than ever on medications that will give sick loved ones some relief. One of the medicines meant to alleviate the misery is phenylephrine, a prominent nasal decongestant on the market today. You may have been stocking up on over-the-counter (OTC) drugs that contain phenylephrine for years, but recent studies indicate you might as well have been taking Skittles or M&Ms.
A recent report by the FDA stated that phenylephrine, the "active" ingredient in many nasal decongestants, is ineffective in relieving symptoms like...well, runny nose. That's a problem, since phenylephrine is included in many OTC meds, including combo drugs such as Advil Sinus Congestion and Pain, Dayquil Cold & Flu, Mucinex Maximum Strength, Nyquil Cold & Flu, Sudafed PE, Flonase Headache and Allergy Relief, and many others.
Phenylephrine arrived on the market in 2006 after another decongestant, called pseudoephedrine (original Sudafed), was taken off OTC pharmacy shelves.
Why? It's an ingredient used in the making of crystal meth. After the passage of the Combat Methamphetamine Epidemic Act of 2005, pseudoephedrine disappeared from view. Thank goodness that, since the law's enactment, meth use is no longer a problem in the United States (says nobody).
Drug companies nimbly adjusted, with the manufacturer of Sudafed putting out a new product with a similar name (Sudafed PE) but with phenylephrine as the main ingredient. Others followed suit with their own products. Well, an FDA panel took a look at the original studies supporting the use of phenylephrine as a nasal decongestant and decided they were "inconsistent." Indeed, in three large studies, phenylephrine turned out to be no better than a placebo, even if used at high doses. It appears that the drug, because it's metabolized in the gut and liver, doesn't reach the bloodstream in sufficient levels to provide relief.
The panel's lead reviewer reported: "We do believe that the original studies were methodologically unsound ... and do not provide evidence that oral phenylephrine is effective as a nasal decongestant." Of course, the review's opinion doesn't require that the FDA remove approval for phenylephrine, but the writing is on the wall. Expect dozens of drugs, some probably in your medicine cabinet right now, to eventually be taken off the market.
The investigation of phenylephrine's efficacy, according to Medpage Today, began as early as 2007 in response to a citizen petition. Big Pharma pressure held off the latest reports for more than 15 years. In that time, how much money have American families been spending buying an ineffective drug? A consumer survey of 100,000 households revealed that about half of them purchased meds containing phenylephrine over the course of a year.
Some advocate keeping phenylephrine on the market because it's considered safe to ingest. In small quantities, so is an M&M or a Skittle, but they won't dry up your nose. Still, consumers get used to buying certain products and will continue buying them even though they don't work.
You might not know that the active ingredient in original Sudafed (pseudoephedrine) is still considered very effective in the relief of nasal congestion and has always been available, despite its utility in the making of methamphetamine. It's always been just behind the counter at the pharmacy. You do have to ask for it (don't request 10,000 tablets), and you must bring your driver's license. Sudafed purchases are documented, so you'll have to sign for them. Law enforcement uses these records in their investigations.
Despite the FDA panel's report, you'll still see phenylephrine products on your pharmacy's shelf tomorrow. While I expect them to be taken off the market, it probably won't happen for a while. That means you should look at the ingredients list of your medicine cabinet's nasal decongestants. You might have some products there that are shooting blanks. Drug companies will scam to find suitable substitutes to put in dozens of combination drugs, but for them, it's an inconvenience. You're the one who's sick.
Face it: someone in your family will probably catch a cold or worse in the next few months. The smart family medic will stock up on pseudoephedrine, not phenylephrine. Just ask the pharmacist for original Sudafed, the real deal.
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