When Medication is an Empty Promise (Sudafed) 

For years I’ve taken pseudoephedrine (a nasal decongestant, the active ingredient in Sudafed) for cold symptoms. I even continued taking it when I had to pick it up from the pharmacy counter, show my ID, and sign a ledger promising that I wouldn’t take it home and convert it to methamphetamine. Pseudoephedrine made my heart race; it made me jittery. It must be working, right? 

Recently we learned that phenylephrine, a close relative of pseudoephedrine that had replaced it as the active ingredient of Sudafed, has no benefit for rhinorrhea, the symptom for which it was most frequently used. It wasn’t better for this indication than placebo. How could we have possibly been so wrong for so long about such a widely used medication?  

It turns out that what we think we know about drugs, especially older over-the-counter medicines like pseudoephedrine, may be based on tradition and bias rather than the highest standards of evidence. There are other notable examples of this phenomenon. Think low-dose aspirin or Vitamin E for primary cardiovascular disease prevention, or digoxin for most forms of congestive heart failure. Randomized trials are the gold standard for proof of benefit, but keep in mind that a single trial can be flawed and that it may require more than one to determine the actual utility of a given intervention. A colleague once told me, “If you really love a drug, then use it before we find out it doesn’t work.” 

It is humbling to know that a medication many of us relied on for years is ineffective. But that didn’t stop me—or most otolaryngologists I know—from recommending Sudafed. Imagine how this makes our patients feel. While many of us in the medical profession are keenly aware of the limitations of science, the public often sees pharmacotherapy as highly regulated and infallible. Recent events like the COVID-19 pandemic may have engendered more distrust for new medicines and vaccines, but over-the-counter agents—including herbal medicines and nutraceuticals—are often not subject to the same degree of suspicion. Part of being an excellent physician is to communicate uncertainty to our patients, especially when it comes to the treatments we recommend. 

What do you tell the patient who, like me, took Sudafed whenever they had a cold? You can now tell them that the best treatment for sinus congestion is saline irrigation. This simple procedure is awkward, and a little bit disgusting. But it works. 

This piece expresses the views solely of the author. It does not necessarily represent the views of any organization, including Johns Hopkins Medicine.