Most OTC decongestants don’t work, says an FDA panel. Now what?

October 12, 2023 | by NorthShore – Edward-Elmhurst Health
Categories: Healthy Driven Life

Have you ever headed to the pharmacy to relieve a stuffy nose? According to new studies, that over-the-counter flu and cold remedy may not have actually done anything to help your symptoms.

In early September, an advisory panel recommended that the Food and Drug Administration (FDA) take all nasal decongestants containing phenylephrine off the shelves. This news comes after extensive research has debunked the ingredient’s effectiveness in treating nasal congestion.

Phenylephrine is a common medication used to treat swollen nasal passages. It has other applications, such as increasing blood pressure and relieving hemorrhoids, but you most likely have seen it in the cold and flu sections of your local pharmacy.  

The ingredient has long been challenged by scientists, starting as far back as 2007. Dr. Leslie Hendeles of the University of Florida School of Pharmacy has led the cause against phenylephrine. He’s long touted research concluding that the pills containing this ingredient are as effective in decongesting your sinuses as taking placebo pills.

The Consumer Healthcare Products Group has argued these studies have flaws and OTC drugs should remain for sale, but the FDA advisory panel unanimously voted in favor of declaring oral formulations of phenylephrine ineffective.

Not all nasal decongestants contain phenylephrine, but the vast majority, including common OTC medications such as Sudafed, Dayquil and others, do. Many brands containing the ingredient are marked with the letters “EP” to distinguish them.

There’s no telling when or if the FDA will act on the panel’s recommendation. In the past, it has taken the regulatory agency years to decades, but recent action in Congress has streamlined the process.

Regardless of whether or not the organization acts to ban the sale of phenylephrine, consumers may want to consider using different drugs and treatments to relieve sinus congestion. Here are three alternatives:

  1. Decongestants with pseudoephedrine. Pseudoephedrine used to be the go-to for decongestion, but the FDA began to require a prescription for the drug after discovering it could be used in the creation of methamphetamine. This treatment is less accessible but effective in relieving nasal congestion
  2. Nasal decongestants with phenylephrine. Studies have shown phenylephrine is more effective when taken in a non-oral form: as a nasal spray or drops. FDA panels have shown no interest in banning these treatments, and they are available over the counter.
  3. Antihistamines. Antihistamines like Zyrtec, Allegra and Claritin are effective treatments for congestion that don’t contain phenylephrine. These may be best for those who need an OTC solution and are sensitive to nasal sprays/drops.

Ask your doctor about the right cold and flu OTC remedy for you.

With hundreds of board-certified physicians to choose from, you’re likely to find the perfect doctor for you close by. Find a doctor at Edward-Elmhurst Health.

Need care now? Our board-certified providers ready to treat your non-emergency urgencies. Find a walk-in location near you.

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