Most Common Cold Medications Don’t Work

We still don’t have a cure for the common cold. However, at your local pharmacy, you can find many shelves stocked with products claiming to treat symptoms.

Well, it turns out that one of the most widely used ingredients, long thought to be effective at treating congestion, doesn’t work at all. The ingredient, phenylephrine, has been used for decades and is found in many cold medications 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 the effectiveness of phenylephrine has never been properly studied. How can this be? It’s FDA approved, which generally means it must be safe and effective, right? Not exactly, as I explain below.

As for phenylephrine: well, the studies have finally been done, and last month an FDA panel unanimously concluded, after reviewing the results, that phenylephrine is unnecessary and no better than a placebo. It probably won’t do you any harm, but it won’t have any effect on your stuffy nose.

To understand how this happened and why this might be true for many other FDA-approved remedies you can buy at the drugstore, you need to know how the FDA approval process has changed over the years. Pharmacists Randy Hatton and Leslie Hendeles, who worked for years to try to get phenylephrine properly revised, explained in a recent New York Times editorial that when the FDA was created in 1938, it was only required to ensure drug safety.

At the time, this was considerable progress. Before 1938, drug manufacturers could claim just about anything they wanted.

But it wasn’t until 24 years later, in 1962, that Congress required the FDA to demonstrate that the drugs were also effective. As a result, the thousands of drugs approved before 1962 were mostly safe, but they may not actually treat the disease they were intended to treat. After 1962, the FDA created a process to check previously approved drugs, but it never had enough staff or funding to check most of them. Phenylephrine has therefore never been properly examined until now.

What’s next for phenylephrine? The FDA could ban it from the market, but that will take time, and it might not happen because the FDA is not required to follow the advice of its panels, even though it usually does. Meanwhile, you can still buy cold remedies containing phenylephrine, and they still claim to treat congestion.

And don’t even get me started on other treatments that are not only ineffective but aren’t even subject to FDA review, like homeopathic remedies. These include Zicam, which claims in large letters on the front of its packaging that it shortens colds. This is not the case, and the maker of Zicams doesn’t even need to prove it, because it is homeopathic. If you zoom in on any of the labels on the Zicam site, you will find the disclaimer that claims [are] based on traditional homeopathic practice and not medical evidence. Not evaluated by the FDA. On some packages I couldn’t even find the fine print.

(Aside: Congress shielded homeopathic preparations from FDA scrutiny in 1938, thanks to a homeopath who was also a US senatorand who helped write the original FDA legislation.)

I wrote about Zicam and other ineffective cold remedies in 2014 (The Five Best Cold Remedies That Don’t Work), and that advice still stands. Now we can add another one to the list.

We simply don’t have any particularly effective cold medications, despite the many claims you can find online and on the labels of so-called cold remedies. The best thing you can do is simply drink warm liquids like tea or lemon-infused water, stay home, and get plenty of rest.