Why you might not be able to find your favorite cold medicine at the drugstore

The FDA says the decongestant phenylephrine is not effective, but there are still options for relieving cold symptoms, according to a UCSF pharmacist.

Author: Levi Gaddy

Winter is here and many people are struggling with runny noses and coughs. For some, that means a trip to the drugstore to refill their cold medicine.

But this year, some drugs have disappeared from drugstore shelves. This is the result of the U.S. Food and Drug Administration’s (FDA) recent conclusion that phenylephrine, a common decongestant, is ineffective. CVS announced in October that it would no longer sell products containing phenylephrine as the only ingredient, including some versions of well-known products like Sudafed PE.

We spoke with Shalini Lynch, PharmD, faculty member in the Department of Clinical Pharmacy and drug information specialist at UCSF, about this new advancement in cold symptom treatment.

Why did the FDA conclude that this common cold medicine is ineffective?

In 2007, some pharmacists petitioned the FDA to review the dosage of phenylephrine, suspecting that over-the-counter doses were too low and ineffective. For over-the-counter medications, the FDA-recommended dosage is generally lower than that for prescription medications because over-the-counter medications are for self-care and do not require physician supervision.

Between 2007 and 2023, the FDA conducted a more comprehensive study of data collected over the years and concluded that phenylephrine was not effective at any dose.

Is there any practical significance to this announcement?

So far, the FDA has not said it is withdrawing the product or stopping production of the product, that’s all. They just clarified that phenylephrine doesn’t have the power we once thought it had. It is still approved for over-the-counter use.

What response measures are pharmacies and pharmaceutical companies taking?

Currently, CVS is the only major pharmacy to change its offerings. Maybe the thinking is, if the product doesn’t work, why offer it? Taking these products off the shelves is a big step for them. I think it’s unclear what will happen to other pharmacies and the supply chain in the long term because so many products contain this ingredient.

Have all products containing phenylephrine been removed from the shelves?

Only CVS is eliminating cold medicines that contain phenylephrine as the only active ingredient. One example is a version of Sudafed called Sudafed PE. Many cold medicines are combination products containing multiple active ingredients, and these products are still available; nothing has changed about these medicines.

I have 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 cold, you’ll need to find a different formula or combination, or try a different pharmacy. Generally speaking, for colds and flu, we recommend single-ingredient products, so if you must use Sudafed PE, you may need to get it from a source other than CVS.

You may also consider other medications. Pseudoephedrine, the decongestant in other Sudafed products, must be purchased over the counter at a pharmacy and is still available.

Any other advice for people with a cold?

Thankfully, colds are usually self-limiting. They can be annoying for a few days and then go away. But if these symptoms are really bothering you, such as if you keep sneezing or coughing, it’s worth finding medications that can help.

MedlinePlus, a website launched by the National Library of Medicine, is a great place to learn how to treat the common cold at home. WebMD is also very good. If you find yourself torn between the many options, the pharmacist behind the counter can help. The FDA’s new guidance comes as no surprise to us at pharmacy and are happy to help you with all of your medications, including those that don’t require a prescription.

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