Popular nasal decongestant doesn’t work. What now?

Based on a review of new data, an FDA panel concluded that a common decongestant, phenylephrine, is not effective for the relief of nasal congestion symptoms when taken orally (pill or liquid) at the recommended dose.¹ Heading into cold and flu season, you may be wondering what this means for products containing this ingredient and what other options are available.

What is phenylephrine?
Phenylephrine (fen-il-ef-rin) is an oral decongestant found in many over-the-counter cold and allergy medications, like DayQuil™, Benadryl® Allergy Plus Congestion, Tylenol® Sinus, and others, including generic products. If a product has ‘PE’ included in the name, like SudafedPE®, it means that it contains phenylephrine.

Phenylephrine is also available as a nasal spray, which is not included in the FDA panel’s conclusions. Nasal application of phenylephrine is still considered to be effective for relieving nasal congestion.

What will happen to products that contain phenylephrine?
The FDA will determine whether to revoke the oral drug’s status as “safe and effective” for nasal decongestion, and whether to remove products containing phenylephrine from the shelves, but the timeline for this is unclear. As many cold remedy products contain phenylephrine in combination with other medications that treat cold-related symptoms, like pain relievers, cough suppressants, and expectorants (to loosen phlegm), the FDA’s decision could result in the removal of these products even if other medications are effective at reducing the symptoms that they target.

If I take products that contain phenylephrine, am I at risk?
The FDA committee did not find any safety concerns at the recommended dose.¹ However, given its lack of effectiveness, there is little benefit to taking phenylephrine.

What are some other options for relieving nasal congestion?

• Oral decongestant – pseudoephedrine
  The only effective oral nasal decongestant remaining on the market is pseudoephedrine (soo-do-eh-feh-drin), which works by shrinking swollen nasal membranes. Pseudoephedrine is found in products like regular Sudafed® (not SudafedPE®). If you choose to treat congestion with an oral medication, read the label and select a product that contains pseudoephedrine as the active ingredient, NOT phenylephrine. Products containing pseudoephedrine are kept behind the pharmacy counter and there is a limit on the amount that can be purchased by an individual. Their sale is regulated because the chemical components can be used to illegally manufacture methamphetamine.

  Pseudoephedrine can cause trouble sleeping, jittery feelings, and elevated blood pressure. Ask your doctor before taking pseudoephedrine, especially if you have any health problems or are taking prescription medications.

• Nasal spray decongestants
  Nasal spray decongestants are a useful option, particularly for those who prefer to avoid oral medications or who have difficulty tolerating the side effects. Options include products containing oxymetazoline (Afrin® and Zicam® Nasal Spray), which relieves nasal congestion by shrinking blood vessels in the nasal passages. There are also products containing a nasal spray form of phenylephrine (Neo-synephrine®), which works to shrink blood vessels when topically applied to the nasal passages and is thus more effective than the oral version.

  Nasal sprays are meant for short-term symptom relief. For over the counter use for a simple cold or congestion, it should be limited to no more than 3 days. Without the guidance of a healthcare professional, overuse of a nasal spray can increase the risk of rebound congestion.

  If symptoms still persist despite 3 days of treatment, they should reach out to their provider. The provider consult can help determine if there is a more complicated infection or rule out rebound congestion. Under the supervision of their doctor, they may prescribe a longer duration of the nasal spray or alternative treatment. Speak with your doctor before using decongestant nasal sprays if you are taking prescription medicines or are pregnant.

  Like oral cold remedies, some nasal sprays contain combinations of several medications (ex. pain reliever, decongestant, and expectorant). Follow the instructions on the product label and avoid using combination sprays if you are already taking one of the other medications in the product.

• Antihistamines

  Antihistamines, which work by blocking allergy receptors, are effective for nasal congestion caused by allergies, but not for congestion caused by cold and flu viruses. Options include non-drowsy formulas like cetirizine (Zyrtec®), fexofenadine (Allegra®), loratadine (Claritin®), and azelastine (Astelin®), as well as chlorpheniramine (Chlor-Trimeton) and diphenhydramine (Benadryl®), which can cause drowsiness.

• Managing congestion without medication
  Standing next to a steamy shower or using a humidifier can help relieve symptoms. Saline nasal sprays and neti-pots (be sure to use sterile or distilled water) can help relieve irritated nasal passages.

References

1. Research, C. for D. E. and. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. FDA (2023).