FDA panel: Popular decongestant labeled ineffective. Here’s what does work.

Published: Sep. 12, 2023 at 10:30 PM CDT
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INDEPENDENCE, Mo. (KCTV) - A popular decongestant in cold and allergy medicines may get pulled from the shelves. On Tuesday an FDA panel voted unanimously that the ingredient phenylephrine is ineffective.

People often refer to it by the brand name Sudafed, but there are two kinds, and the boxes look similar. The original Sudafed, pseudoephedrine, is effective but a little harder to get. You don’t need a prescription, but you have to go to the pharmacy counter, present your driver’s license and sign for it. A 2006 law added that regulation, because people were buying it in large quantities to make meth.

The one you can buy right off the the shelf includes phenylephrine as the active ingredient. Sudafed markets it as Sudafed PE. It’s also in common combo medicines like DayQuil and Theraflu. That’s the ingredient that the FDA panel agreed was no more effective than a placebo.

“I think they’ve looked at it pretty analytically, and they’ve looked at several big studies,” said Dr. Todd Fristo. “I think they really looked at it very thoroughly.”

Fristo is a family medicine physician at Saint Luke’s Primary Care—Independence.

The drugs haven’t been pulled from the shelves yet. The panel’s recommendation isn’t binding, so the FDA does not have to order them removed.

If you’re looking for an alternative, there are a few things to consider. First, know the difference between a which symptoms call for a decongestant and which call for an antihistamine.

“Decongestants are simply for nasal congestion where your nose plugged up and you can’t get air in and out,” said Fristo. “If you have a lot of runny nose, or what we call rhinorrhea, or post nasal drainage, and there’s not congestion, especially this time of year with the ragweed, that’s where you would consider an antihistamine. That will help dry the nasal passages out and reduce the amount of mucus that your nasal passages and sinuses produce.”

Next, consider any other health conditions you have. Pseudoephedrine is effective, but it can get your heart racing and raise your blood pressure. That means someone with high blood pressure or a heart arrhythmia should proceed with caution.

“You have to be careful with it,” Fristo said, “but if used appropriately in a proper dosage, it’s generally a pretty effective medication for nasal congestion.”

He does not recommend it for children under the age of 12. Good options for them and for adults who want to avoid drugs include rubbing Vicks under their nose, using a Vicks nasal inhaler, or using a saline nasal spray.

“That tends to help shrink the mucous membranes down a little bit and help that stuff kind of flush out of there,” Fristo said of saline sprays.

The panel’s opinion on phenylephrine opens the door for the FDA to pull it from a federal list of decongestants deemed effective for over-the-counter pills and liquids. Any action taken should not be an indication that what you’ve been taking is unsafe. The FDA said removing the products would eliminate “unnecessary costs and delay in care of taking a drug that has no benefit.”