We still don’t have a cure for the common cold. In your local pharmacy, though, you can find many shelves filled with products that claim to treat the symptoms.
Well, it turns out that one of the most widely-used ingredients, long believed to be effective at treating congestion, doesn’t work at all. The ingredient, phenylephrine, has been in use for decades, and it’s in many common cold medicines that are taken by millions of people each year, including Nyquil Severe, Sudafed PE, Robitussin CF, Tylenol Cold & Flu, and others.
It turns out that phenylephrine was never properly studied for effectiveness. How can this be? It’s FDA approved, which usually means it has to be safe and effective, right? Not exactly, as I explain below.
As for phenlyephrine: well, the studies have finally been done, and last month an FDA panel unanimously concluded, after reviewing the results, that phenlyephrine is “useless and no better than a placebo.” It probably won’t cause you any harm, but it won’t have any effect on your stuffy nose.
To understand how this happened–and why it might be true of many other FDA-approved remedies that you can buy at the pharmacy–you have to know about how the FDA approval process has changed over the years. Pharmacists Randy Hatton and Leslie Hendeles, who worked for years trying to get phenylephrine properly reviewed, explained in a recent New York Times editorial that when the FDA was originally created, way back in 1938, it was only required to ensure that drugs were safe.
At the time, that was tremendous progress. Prior to 1938, drug manufacturers could claim pretty much whatever they wanted to.
But it wasn’t under 24 years later, in 1962, that Congress required the FDA to show that drugs were also effective. Therefore the thousands of drugs approved prior to 1962 were mostly safe, but they might not actually treat the disease they were intended to treat. After 1962, the FDA created a process to check those previously-approved drugs, but they’ve never had enough staff or funding to check most of them. So phenylephrine was never properly reviewed, until now.
What’s next for phenylephrine? The FDA might ban it from the market, but that will take time, and it might not happen, because the FDA doesn’t have to follow the advice of its panels, although it usually does. Meanwhile, you can still buy cold remedies with phenylephrine, and they still claim to treat congestion.
And don’t even get me started on other treatments that are not only ineffective, but that aren’t even subject to review by the FDA, such as homeopathic remedies. These include Zicam, which claims in large print on the front of its packaging that it “shortens colds.” It doesn’t, and Zicam’s manufacturer doesn’t even have to prove it, because it’s homeopathic! If you zoom way in one of the labels on the Zicam website, you’ll find the disclaimer that “Claims [are] based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.” On some of the packages, I couldn’t even find the small print.
(Aside: Congress protected homeopathic preparations from FDA scrutiny way back in 1938, thanks to a homeopath who was also a U.S. Senator, and who helped write the original FDA legislation.)
I wrote about Zicam and other ineffective cold remedies back in 2014 (”The Top Five Cold Remedies that Do Not Work”), and that advice still holds.
We simply don’t have any drugs that work particularly well for the common cold, despite the many claims you can find online and on the labels of so-called cold remedies. The best thing you can do is just drink warm liquids such as tea or lemon-infused water, stay home, and get plenty of rest.
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