America’s Favorite Nasal Decongestant To Be Pulled From the Shelves?

In recent news, the U.S. Food and Drug Administration (FDA) announced a proposal to remove oral phenylephrine from over-the-counter (OTC) medications for nasal congestion.¹

The FDA is saying that oral phenylephrine doesn’t work as advertised for stuffy noses, so they may take steps to remove it from the market. They encourage consumers to explore other safe and effective options for congestion relief.

What’s happening with phenylephrine?

The FDA reviewed available data and found oral phenylephrine to be ineffective as a nasal decongestant. This decision is based on efficacy, not safety concerns.

They conducted a thorough review of all available data, including older data used in the 1994 decision to approve its use, as well as more recent studies, including environmental exposure unit studies, and newer clinical trials. Essentially, they wanted to see if the old findings still held up in light of new research.

A key issue they found was how nasal congestion was measured. Older studies relied heavily on “nasal airway resistance” (NAR), a measure of airflow. However, the FDA now recognizes that patient-reported symptom scores are a more reliable way to assess actual congestion relief. 

NAR measurements are complex and prone to variability, and there’s no strong evidence that improvements in NAR translate to real-world symptom improvement. This suggests that the initial approval of oral phenylephrine may have been based on flawed data, prompting the FDA’s current proposal to remove it.²

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., Director of the FDA’s Center for Drug Evaluation and Research (CDER) in a recent news release¹. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

What is phenylephrine? 

It’s a common ingredient in many over-the-counter cold and allergy medications used to relieve stuffy noses. 

These medications may contain phenylephrine as their only active ingredient, or they may combine it with other ingredients like acetaminophen for pain relief or dextromethorphan for cough suppression. It’s important to note that in these combination products, the potential removal of phenylephrine would not affect the way the other active ingredients work to treat their intended symptoms.^3,4

Phenylephrine works by narrowing blood vessels in the nasal passages.³ It works by targeting specific receptors on the walls of blood vessels in the nose, called alpha-1 adrenergic receptors. When stimulated, these receptors cause the blood vessels to constrict, which reduces blood flow to the nasal tissues and ultimately decreases swelling. This reduced swelling then makes it easier to breathe.

What products are affected? 

This announcement applies only to oral phenylephrine (pills and liquids), not nasal sprays containing phenylephrine. Some medications contain only phenylephrine, while others combine it with other active ingredients like acetaminophen (for pain) or dextromethorphan (for cough). This action targets only the phenylephrine component.

What happens next?

• This is a proposal, not a final decision.
• The FDA is seeking public comment on the proposal.
• If the FDA issues a final order, manufacturers will need to reformulate or remove products containing oral phenylephrine as a nasal decongestant.

What should consumers do?

• Be aware of this potential change.
• Always read the Drug Facts label to see what ingredients are in your medications.
• Talk to your doctor or pharmacist if you have questions about alternative treatments for nasal congestion.

References

1. Commissioner, O. of the (no date) FDA proposes ending use of oral phenylephrine as OTC monograph nasal decongestant active ingredient after extensive review, U.S. Food and Drug Administration. Available at: https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after (Accessed: 16 November 2024). 
2. (No date) Scientific Review Supporting Proposed Administrative Order. Available at: https://dps-admin.fda.gov/omuf/sites/omuf/files/supporting-documents/2024-11/Scientific%20Review%20for%20Proposed%20Administrative%20Order%20OTC000036%20-%20Amending%20OTC%20M012_0.pdf (Accessed: 04 November 2024). 
3. Richards E, Lopez MJ, Maani CV. Phenylephrine. In: StatPearls. Treasure Island (FL): StatPearls Publishing; October 30, 2023.
4. Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007;41(3):381-390. doi:10.1345/aph.1H679