The active ingredient in some popular over-the-counter cold and flu medications doesn’t actually help get rid of a stuffy nose, the Food and Drug Administration announced.
The oral version of phenylephrine — a nasal decongestant — was examined by a 16-advisor FDA board to determine its efficacy in relieving the symptoms of congestion.
The two-day review ended Sept. 12 with the conclusion that oral versions of the drug, which is the main ingredient in Nyquil, Sudafed PE and Mucinex, doesn’t work.
In supplementary documents shared during the review, data from multiple studies showed phenylephrine did not perform better than placebo drugs in helping to relieve cold and allergy congestion among patients.
Studies found that only a very small amount of the drug reaches the sinuses after a patient consumes the medication orally, according to the review documents, CNBC reported.
Liquid and spray versions of phenylephrine were not included in the review.
So, as flu season is ramping up across the country, what medications should you take to relieve uncomfortable clogged noses?
What was phenylephrine supposed to do?
Phenylephrine was created to decrease congestion in the nose and sinuses by constricting, or shrinking, the blood vessels, reducing swelling and opening up the airways, according to Medline Plus, a federal drug information database.
The drug was never intended to treat the cause of the congestion, like a sinus infection or the flu, but it was marketed as a way to ease symptoms and make a cold a little more manageable.
Slogans like “You’ve got symptoms. We’ve got relief” and “Start the Relief. Ditch the Misery” from Mucinex campaigns have dominated TV advertisements, particularly in fall and winter months.
Drugs that include phenylephrine in their ingredients generated $1.8 billion in sales in 2022, according to the advisory review briefing documents CNN reported.
But phenylephrine had risks before it was deemed ineffective.
As the drug constricts the blood vessels in the nose, it can also negatively impact other blood pathways in the body.
The warning label on medications with the drug recommended people with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating to stay clear of the decongestant, according to Harvard Medical School.
For those without pre-existing heart conditions, phenylephrine is safe to use, though it might not help with your head cold.
There are other drugs that are available over the counter that can help with congestion without the heart risk.
If you would still like to take a pill, antihistamines such as diphenhydramine, the active ingredient in Benadryl; chlorpheniramine, the active ingredient in Chlor-Trimeton; cetirizine, the active ingredient in Zyrtec; and loratadine, the active ingredient in Claritin, are safe for the heart and can help release the pressure in your nose, according to Harvard Medical School.
You can also opt for a nasal spray, such as Flonase or Afrin, that has less severe cardiovascular effects, Harvard Medical School says.
There are also ways to decrease congestion without any medication at all.
Breathe Right offers a nasal strip that is placed across the bridge of the nose and opens airways.
You can also pour salinated water through your sinuses using a neti pot, washing out mucus and decreasing pressure in the sinuses.
Harvard Medical School also recommends hot showers or a hot towel wrapped around the face, drinking lots of fluids and hot beverages, and even eating spicy foods to keep mucus moist and flowing.
It starts with prevention
The best way to deal with a congested nose is to avoid the illness altogether.
Flu and RSV vaccines are now available for the fall season.
Flu vaccines are recommended for everyone over the age of 6 months on an annual basis, according to the Centers for Disease Control and Prevention.
RSV vaccinations are available for the first time this year and are recommended for adults 60 years and older, according to the CDC.
The vaccines are safe to get at the same time, the CDC says, along with the updated COVID-19 booster.
Experts recommend talking to your healthcare provider before making vaccination decisions.
Find a location to receive a flu shot, RSV vaccine or updated COVID-19 booster at vaccines.gov.