It’s winter and many people are contending with the sniffles and coughs. For some, that means heading to the pharmacy to resupply on cold medications.
But this year, some have gone missing from pharmacy shelves. It’s the consequence of a recent conclusion by the U.S. Food and Drug Administration (FDA) that phenylephrine, a common decongestant, isn’t effective. CVS announced in October that it would no longer carry products containing phenylephrine as their only ingredient, including certain versions of well-known products like Sudafed PE.
We spoke with UC San Francisco’s Shalini Lynch, PharmD, faculty member in the Department of Clinical Pharmacy and an expert on drug information, about this new development in treatments for cold symptoms.
Why did the FDA conclude that this common cold med isn’t effective?
In 2007, some pharmacists petitioned the FDA to review the dosage of phenylephrine, suspecting that the over-the-counter dose was too low and not effective. Often with over-the-counter drugs, the FDA recommends lower doses than what we see in prescription medications, because over-the-counter meds are used for self-care without physician supervision.
Between 2007 and 2023, the FDA conducted a more comprehensive look at data collected over these years and concluded that phenylephrine isnt effective at any dose.
Does this announcement have any teeth to it?
So far, the FDA has not said “pull the product” or “stop making the product,” nothing like that. They’ve just clarified that phenylephrine doesn’t have the efficacy that we once thought it might. It’s still approved for over-the-counter use.
What are pharmacies and drug manufacturers doing in response?
Right now, CVS is the only major pharmacy that’s changed its offerings. Perhaps the thinking is, Why offer a product if it’s not going to work? It’s a big step for them to remove these products from the shelves. I think it’s unclear what will happen in the long term with other pharmacies and with the supply chain, since so many products contain this ingredient.
Are all products with phenylephrine being pulled?
Only CVS is removing cold medications that contain phenylephrine as the sole active ingredient. One example is one version of Sudafed, called Sudafed PE. Many cold medications are combination products, with several active ingredients, and those products will still be available; nothing is changing for those medications.
I’ve relied on Sudafed PE for years. What should I do now?
If you can’t find the exact product you’ve been using to treat your colds, you’ll need to find a different formulation, or combination, or try a different pharmacy. Generally speaking, where cold and flu is concerned, we recommend using single-ingredient products, so if you must use Sudafed PE, you may need to obtain it from a source other than CVS.
You might also consider other medications. Pseudoephedrine, the decongestant found in other Sudafed products, must be purchased at the pharmacy counter, and is still available.
Any other advice for people who’ve come down with a cold?
Colds, thankfully, are usually self-limiting. They’re annoying for a few days and then tend to fade. But if the symptoms are really bothering you, like if you’re sneezing or coughing all of the time, it’s worth it to find a medication that can help.
MedlinePlus is a website put out by the National Library of Medicine that can be a great place to learn about treating the common cold at home. WebMD is pretty good too. And the pharmacist behind the counter can help, if you find yourself torn between the many options. The FDA’s new guidance was no surprise to those of us in pharmacy, and we’re happy to help you with all medications, including those that don’t require a prescription.