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As cold and flu season approaches, families are stocking up on medications that take away some of the misery experienced by those infected by viruses. One of these medicines is phenylephrine, a prominent nasal decongestant on the market today. You may have been stocking up on OTC drugs that contain phenylephrine for years, but recent studies indicate you might as well have been taking Skittles.
A recent report by the FDA stated that phenylephrine, the “active” ingredient in many nasal decongestants, is ineffective in relieving symptoms like runny nose. Phenylephrine arrived on the market in 2006 after another decongestant, called pseudoephedrine (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. Since then, meth use is no longer a problem in the United States (says nobody). More on that later
Drug companies quickly 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, phenylephrine turns out to be no better than a placebo, even if used at high doses.
The panel reported: “We do believe that the original studies were methodologically unsound and do not match today’s standard…. and do not provide evidence that oral phenylephrine is effective as a nasal decongestant.”
The investigation of phenylephrine, 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 purchased meds containing phenylephrine over the course of a year.
Pseudoephedrine is still considered effective against nasal congestion
Interestingly, pseudoephedrine, the similar-sounding active ingredient in original Sudafed, 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. All you have to do is ask for it (and not request 10,000 tablets). Bring your driver’s license, as Sudafed purchases are documented; you’ll have to sign for them.
Despite the FDA panel’s report, the FDA, at present, still allows the purchase of phenylephrine products. While I expect them to eventually take products containing it off the market, it probably won’t happen for a while. That means you’ll have to look at the ingredients list of your medicine cabinet’s nasal decongestants. You might have some products there that are shooting blanks.
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 the original Sudafed, the real deal. It’s still over the counter, and just behind the counter.
Joe Alton MD
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